Laparoscopic versus open resection for sigmoid diverticulitis.
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ABSTRACT:
SUBMITTER: Abraha I
PROVIDER: S-EPMC6486209 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ImportanceDiverticulitis has a tendency to recur and affect quality of life.ObjectiveTo assess whether sigmoid resection is superior to conservative treatment in improving quality of life of patients with recurrent, complicated, or persistent painful diverticulitis.Design, setting, and participantsThis open-label randomized clinical trial assessed for eligibility 128 patients with recurrent, complicated, or persistent painful diverticulitis in 6 Finnish hospitals from September 29, 2014, to October 10, 2018. Exclusion criteria included age younger than 18 years or older than 75 years; lack of (virtual) colonoscopy or sigmoidoscopy data within 2 years, or presence of cancer, contraindication to laparoscopy, or fistula. Outcomes were assessed using intention-to-treat analysis. A prespecified interim analysis was undertaken when 66 patients had been randomized and their 6-month follow-up was assessable. Data were analyzed from June 2018 to May 2020.InterventionsLaparoscopic sigmoid resection or conservative treatment.Main outcomes and measuresThe primary outcome was difference in Gastrointestinal Quality of Life Index (GIQLI) score between randomization and 6 months.ResultsOf 128 patients assessed for eligibility, 90 were randomized (28 male [31%]; mean [SD] age, 54.11 [11.9] years; 62 female [69%]; mean [SD] age, 57.13 [7.6] years). A total of 72 patients were included in analyses for the primary outcome (37 in the surgery group and 35 in the conservative treatment group), and 85 were included in analyses for clinical outcomes (41 in the surgery group and 44 in the conservative treatment group). The difference between GIQLI score at randomization and 6 months was a mean of 11.96 points higher in the surgery group than in the conservative treatment group (mean [SD] of 11.76 [15.89] points vs -0.2 [19.07] points; difference, 11.96; 95% CI, 3.72-20.19; P = .005). Four patients (10%) in the surgery group and no patients in the conservative treatment group experienced major complications (Clavien-Dindo grade III or higher). There were 2 patients (5%) in the surgery group and 12 patients (31%) in the conservative treatment group who had new episodes of diverticulitis within 6 months.Conclusions and relevanceIn this randomized clinical trial, elective laparoscopic sigmoid resection improved quality of life in patients with recurrent, complicated, or persistent painful diverticulitis but carried a 10% risk of major complications.Trial registrationClinicalTrials.gov Identifier: NCT02174926.
| S-EPMC7675217 | biostudies-literature
Project description:BackgroundLaparoscopic peritoneal lavage is an alternative to sigmoid resection in selected patients presenting with purulent peritonitis from perforated diverticulitis. Although recent trials have lacked superiority for lavage in terms of morbidity, mortality was not compromised, and beneficial secondary outcomes were shown. These included shorter duration of surgery, less stoma formation and less surgical reintervention (including stoma reversal) for laparoscopic lavage versus sigmoid resection respectively. The cost analysis of laparoscopic lavage for perforated diverticulitis in the Ladies RCT was assessed in the present study.MethodsThis study involved an economic evaluation of the randomized LOLA (LaparOscopic LAvage) arm of the Ladies trial (comparing laparoscopic lavage with sigmoid resection in patients with purulent peritonitis due to perforated diverticulitis). The actual resource use per individual patient was documented prospectively and analysed (according to intention-to-treat) for up to 1 year after randomization.ResultsEighty-eight patients were randomized to either laparoscopic lavage (46) or sigmoid resection (42). The total medical costs for lavage were lower (mean difference € - 3512, 95 per cent bias-corrected and accelerated c.i. -16 020 to 8149). Surgical reintervention increased costs in the lavage group, whereas stoma reversal increased costs in the sigmoid resection group. Differences in favour of laparoscopy were robust when costs were varied by ±20 per cent in a sensitivity analysis (mean cost difference € - 2509 to -4438).ConclusionLaparoscopic lavage for perforated diverticulitis is more cost-effective than sigmoid resection.
| S-EPMC6681137 | biostudies-literature
Project description:ImportanceBoth elective sigmoid resection and conservative treatment are options for patients with recurrent, complicated, or persistent painful diverticulitis; understanding outcomes following each can help inform decision-making.ObjectiveTo compare outcomes of elective sigmoid resection and conservative treatment for patients with recurrent, complicated, or persistent painful diverticulitis at 2-year follow-up.Design, setting, and participantsThis multicenter parallel open-label individually randomized clinical trial comparing elective sigmoid resection to conservative treatment in patients with recurrent, complicated, or persistent painful diverticulitis was carried out in 5 Finnish hospitals between September 2014 and October 2018. Follow-up up to 2 years is reported. Of 85 patients randomized and included, 75 and 70 were available for QOL outcomes at 1 year and 2 years, respectively, and 79 and 78 were available for the recurrence outcome at 1 year and 2 years, respectively. The present analysis was conducted from September 2015 to June 2022.InterventionsLaparoscopic elective sigmoid resection vs conservative treatment (patient education and fiber supplementation).Main outcomes and measuresPrespecified secondary outcomes included Gastrointestinal Quality of Life Index (GIQLI) score, complications, and recurrences within 2 years.ResultsNinety patients (28 male [31%]; mean [SD] age, 54.11 [11.9] years and 62 female [69%]; mean [SD] age, 57.13 [7.6] years) were randomized either to elective sigmoid resection or conservative treatment. After exclusions, 41 patients in the surgery group and 44 in the conservative group were included in the intention-to-treat analyses. Eight patients (18%) in the conservative treatment group underwent sigmoid resection within 2 years. The mean GIQLI score at 1 year was 9.51 points higher in the surgery group compared to the conservative group (mean [SD], 118.54 [17.95] vs 109.03 [19.32]; 95% CI, 0.83-18.18; P = .03), while the mean GIQLI score at 2 years was similar between the groups. Within 2 years, 25 of 41 patients in the conservative group (61%) had recurrent diverticulitis compared to 4 of 37 patients in the surgery group (11%). Four of 41 patients in the surgery group (10%) and 2 of 44 in the conservative group (5%) had major postoperative complications within 2 years. In per-protocol analyses, the mean (SD) GIQLI score was higher in the surgery group compared to the conservative treatment group by 11.27 points at 12 months (119.42 [17.98] vs 108.15 [19.28]; 95% CI, 2.24-20.29; P = .02) and 10.43 points at 24 months (117.24 [15.51] vs 106.82 [18.94]; 95% CI, 1.52-19.33; P = .02).Conclusions and relevanceIn this randomized clinical trial, elective sigmoid resection was effective in preventing recurrent diverticulitis and improved quality of life over conservative treatment within 2 years.Trial registrationClinicalTrials.gov Identifier: NCT02174926.
| S-EPMC10116381 | biostudies-literature
Project description:To compare surgical and oncological outcomes of laparoscopic versus open liver resection for colorectal liver metastases.A total of 14 retrospective studies with 1679 colorectal liver metastases patients were analyzed: 683 patients treated with laparoscopic liver resection and 996 patients with open liver resection. With respect to surgical outcomes, laparoscopic compared with open liver resection was associated with lower blood loss (MD, -216.7, 95% CI, -309.4 to -124.1; P < 0.00001), less requiring blood transfusion (OR, 0.36; 95% CI, 0.23 to 0.55; P < 0.00001), lower postoperative complication morbidity (OR, 0.61; 95% CI, 0.47 to 0.80; P = 0.003), and shorter hospitalization time (MD, -3.85, 95% CI, -5.00 to -2.71; P < 0.00001). However, operation time and postoperative mortality were no significant difference between the two approaches. With respect to oncological outcomes, laparoscopic liver resection group was prone to lower recurrence rate (OR, 0.78; 95% CI, 0.61-0.99; P = 0.04), but surgical margins R0, overall survival and disease-free survival were no significant difference.We performed a systematic search in MEDLINE, EMBASE, and CENTRAL for all relevant studies. All statistical analysis was performed using Review Manager version 5.3. Dichotomous data were calculated by odds ratio (OR) and continuous data were calculated by mean difference (MD) with 95% confidence intervals (CI).Laparoscopic and open liver resection for colorectal liver metastases have the same effect on oncological outcomes, but laparoscopic liver resection achieves better surgical outcomes.
| S-EPMC5356680 | biostudies-literature
Project description:Purulent peritonitis from acute left colon diverticulitis is a relatively common presentation of diverticular disease; historically the treatment was the Hartmann procedure. Laparoscopic peritoneal lavage has been proposed as a lesser invasive treatment option with great interest and debate among surgeons and with contrasting results. The aim of this meta-analysis was to compare the results of sigmoid resection with laparoscopic lavage.A systematic review was performed to select randomized controlled trials comparing laparoscopic lavage versus resection in Hinchey III diverticulitis. Studies' selection, data extraction and risk of bias assessment were done by two independent authors; results were shown as OR with 95 % C.I.Three RCT were selected for the meta-analysis including 315 patents. Laparoscopic lavage was associated with significantly more reoperations (OR 3.75, p?=?0.006) and more intra-abdominal abscesses (OR 3.50, p?=?0.0003) with no differences in mortality (OR 0.93, p?=?0.92). At 12 months follow up laparoscopic lavage was associated with lesser reoperations (OR 0.32, p?=?0.0004); there were no differences in term of stoma presence (OR 0.44 p?=?0.27) and mortality (OR 0.74 p?=?0.51).The present meta-analysis shows that in acute perforated diverticulitis with purulent peritonitis laparoscopic lavage is comparable to sigmoid resection in term of mortality but it is associated with a significantly higher rate of reoperations and a higher rate of intra-abdominal abscess. No differences in term of mortality were demonstrated at follow-up. Further studies are needed to better define the safety and appropriateness of this treatment.
| S-EPMC5006586 | biostudies-other
Project description:ImportancePerforated colonic diverticulitis usually requires surgical resection, with significant morbidity. Short-term results from randomized clinical trials have indicated that laparoscopic lavage is a feasible alternative to resection. However, it appears that no long-term results are available.ObjectiveTo compare long-term (5-year) outcomes of laparoscopic peritoneal lavage and primary resection as treatments of perforated purulent diverticulitis.Design, setting, and participantsThis international multicenter randomized clinical trial was conducted in 21 hospitals in Sweden and Norway, which enrolled patients between February 2010 and June 2014. Long-term follow-up was conducted between March 2018 and November 2019. Patients with symptoms of left-sided acute perforated diverticulitis, indicating urgent surgical need and computed tomography-verified free air, were eligible. Those available for trial intervention (Hinchey stages <IV) were included in the long-term follow-up.InterventionsPatients were assigned to undergo laparoscopic peritoneal lavage or colon resection based on computer-generated, center-stratified block randomization.Main outcomes and measuresThe primary outcome was severe complications within 5 years. Secondary outcomes included mortality, secondary operations, recurrences, stomas, functional outcomes, and quality of life.ResultsOf 199 randomized patients, 101 were assigned to undergo laparoscopic peritoneal lavage and 98 were assigned to colon resection. At the time of surgery, perforated purulent diverticulitis was confirmed in 145 patients randomized to lavage (n = 74) and resection (n = 71). The median follow-up was 59 (interquartile range, 51-78; full range, 0-110) months, and 3 patients were lost to follow-up, leaving a final analysis of 73 patients who had had laparoscopic lavage (mean [SD] age, 66.4 [13] years; 39 men [53%]) and 69 who had received a resection (mean [SD] age, 63.5 [14] years; 36 men [52%]). Severe complications occurred in 36% (n = 26) in the laparoscopic lavage group and 35% (n = 24) in the resection group (P = .92). Overall mortality was 32% (n = 23) in the laparoscopic lavage group and 25% (n = 17) in the resection group (P = .36). The stoma prevalence was 8% (n = 4) in the laparoscopic lavage group vs 33% (n = 17; P = .002) in the resection group among patients who remained alive, and secondary operations, including stoma reversal, were performed in 36% (n = 26) vs 35% (n = 24; P = .92), respectively. Recurrence of diverticulitis was higher following laparoscopic lavage (21% [n = 15] vs 4% [n = 3]; P = .004). In the laparoscopic lavage group, 30% (n = 21) underwent a sigmoid resection. There were no significant differences in the EuroQoL-5D questionnaire or Cleveland Global Quality of Life scores between the groups.Conclusions and relevanceLong-term follow-up showed no differences in severe complications. Recurrence of diverticulitis after laparoscopic lavage was more common, often leading to sigmoid resection. This must be weighed against the lower stoma prevalence in this group. Shared decision-making considering both short-term and long-term consequences is encouraged.Trial registrationClinicalTrials.gov Identifier: NCT01047462.
| S-EPMC7758831 | biostudies-literature
Project description:PurposePerforated diverticulitis often requires surgery with a colon resection such as Hartmann's procedure, with inherent morbidity. Recent studies suggest that laparoscopic lavage may be an alternative surgical treatment. The aim of this study was to compare re-operations, morbidity, and mortality as well as health economic outcomes between laparoscopic lavage and colon resection for perforated purulent diverticulitis.MethodsPubMed, Cochrane, Centre for Reviews and Dissemination, and Embase were searched. Published randomized controlled trials and prospective and retrospective cohorts with laparoscopic lavage and colon resection as interventions were identified. Trial limitations were assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. Re-operations, complications at 90 days classified according to Clavien-Dindo and mortality were extracted.ResultsThree randomized trials published between 2005 and 2015 were included in the analysis. The studies included a total of 358 patients with 185 patients undergoing laparoscopic lavage. At 12 months, the relative risk of having a re-operation was lower for laparoscopic lavage compared to colon resection in the two trials that had a 12 month follow-up. We found no significant differences in Clavien-Dindo complications classified more than level IIIB or mortality at 90 days.ConclusionsThe risk for re-operations within the first 12 months after index surgery was lower for laparoscopic lavage compared to colon resection, with overall comparable morbidity and mortality. Furthermore, Hartmann's resection was more costly than laparoscopic lavage. We therefore consider laparoscopic lavage a valid alternative to surgery with resection for perforated purulent diverticulitis.
| S-EPMC5285409 | biostudies-literature
Project description:BackgroundNatural orifice transluminal endoscopic surgery (NOTES) is the consequence of further development of minimally invasive surgery to reduce abdominal incisions and surgical trauma. The potential benefits are expected to be less postoperative pain, faster convalescence, and reduced risk for incisional hernias and wound infections compared to conventional methods. Recent clinical studies have demonstrated the feasibility and safety of transvaginal NOTES, and transvaginal access is currently the most frequent clinically applied route for NOTES procedures. However, despite increasing clinical application, no firm clinical evidence is available for objective assessment of the potential benefits and risks of transvaginal NOTES compared to the current surgical standard.MethodsThe TRANSVERSAL trial is designed as a randomized controlled trial to compare transvaginal hybrid NOTES and laparoscopic-assisted sigmoid resection. Female patients referred to elective sigmoid resection due to complicated or reoccurring diverticulitis of the sigmoid colon are considered eligible. The primary endpoint will be pain intensity during mobilization 24 hours postoperatively as measured by the blinded patient and blinded assessor on a visual analogue scale (VAS). Secondary outcomes include daily pain intensity and analgesic use, patient mobility, intraoperative complications, morbidity, length of stay, quality of life, and sexual function. Follow-up visits are scheduled 3, 12, and 36 months after surgery. A total sample size of 58 patients was determined for the analysis of the primary endpoint. The confirmatory analysis will be performed based on the intention-to-treat (ITT) principle.DiscussionThe TRANSVERSAL trial is the first study to compare transvaginal hybrid NOTES and conventionally assisted laparoscopic surgery for colonic resection in a randomized controlled setting. The results of the TRANSVERSAL trial will allow objective assessment of the potential benefits and risks of NOTES compared to the current surgical standard for sigmoid resection.Trial registrationThe trial protocol was registered in the German Clinical Trials Register ( DRKS00005995) on March 27, 2014.
| S-EPMC4246541 | biostudies-literature
Project description:BackgroundHartmann's procedure for perforated diverticulitis can be characterised by high morbidity and mortality rates. While the scientific community focuses on laparoscopic lavage as an alternative for laparotomy, the option of laparoscopic sigmoidectomy seems overlooked. We compared morbidity and hospital stay following acute laparoscopic sigmoidectomy (LS) and open sigmoidectomy (OS) for perforated diverticulitis.MethodsThis retrospective cohort parallel to the Ladies trial included patients from 28 Dutch academic or teaching hospitals between July 2010 and July 2014. Patients with LS were matched 1:2 to OS using the propensity score for age, gender, previous laparotomy, CRP level, gastrointestinal surgeon, and Hinchey classification.ResultsThe propensity-matched cohort consisted of 39 patients with LS and 78 patients with OS, selected from a sample of 307 consecutive patients with purulent or faecal perforated diverticulitis. In both groups, 66 % of the patients had Hartmann's procedure and 34 % had primary anastomosis. The hospital stay was shorter following LS (LS 7 vs OS 9 days; P = 0.016), and the postoperative morbidity rate was lower following LS (LS 44 % vs OS 66 %; P = 0.016). Mortality was low in both groups (LS 3 % vs OS 4 %; P = 0.685). The stoma reversal rate after Hartmann's procedure was higher following laparoscopy, with a probability of being stoma-free at 12 months of 88 and 62 % in the laparoscopic and open groups, respectively (P = 0.019). After primary anastomosis, the probability of reversal was 100 % in both groups.ConclusionsIn this propensity score-matched cohort, laparoscopic sigmoidectomy is superior to open sigmoidectomy for perforated diverticulitis with regard to postoperative morbidity and hospital stay.
| S-EPMC4992031 | biostudies-literature
Project description:BackgroundData on the safety and feasibility of laparoscopic versus open resection for gastric gastrointestinal stromal tumors (GISTs) larger than 5 cm are limited. Therefore, the aim of this meta-analysis was to compared laparoscopic and open resection for gastric GISTs larger than 5 cm.MethodsWe perform a literature search on PubMed, the Cochrane Library, and Embase. Review Manage version 5.1 (RevMan 5.1) was used for data analysis. The GRADE profiler software (version 3.6) was used to estimate the level of evidence.ResultsA total of 6 observational studies and one unpublished retrospective cohort study met the inclusion criteria for the meta-analysis: 203 patients in LAP and 214 patients in OPEN group. The pooled result revealed that laparoscopic resection was associated with a same operative time (WMD = -0.87 min; 95% CI: -47.50 to 47.75; P = 0.97), intraoperative blood loss (WMD = -34.38 ml; 95% CI: -79.60 to 10.84; P = 0.14), overall complications (RR = 0.65; 95% CI: 0.38 to 1.12; P = 0.12), better 5-year disease-free survival (HR = 0.40; 95% CI: 0.17 to 0.91; P = 0.03) and overall survival (HR = 0.09; 95% CI: 0.02 to 0.40; P = 0.002) compared with open resection.ConclusionLaparoscopic resection is a technically and oncologically safe and feasible approach for large-sized gastric GISTs (? 5 cm) compared to open resection.
| S-EPMC5683318 | biostudies-literature