Dataset Information

The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Natural 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.

Methods

The 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.

Discussion

The 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 registration

The trial protocol was registered in the German Clinical Trials Register ( DRKS00005995) on March 27, 2014.

SUBMITTER: Senft JD

PROVIDER: S-EPMC4246541 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.

Senft Jonas D JD Warschkow Rene R Diener Markus K MK Tarantino Ignazio I Steinemann Daniel C DC Lamm Sebastian S Simon Thomas T Zerz Andreas A Müller-Stich Beat P BP Linke Georg R GR

Trials 20141120

<h4>Background</h4>Natural 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 ...[more]

PMID: 25414061

Similar Datasets

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.

Project description:BackgroundAs an emerging technology, robot-assisted surgical system has some potential merits in many complicated endoscopic procedures compared with laparoscopic surgery. But robot-assisted liver resection is still a controversial problem on its advantages compared with laparoscopic liver resection. We aimed to perform the meta-analysis to assess and compare the clinical outcomes of robot-assisted and laparoscopic liver resection.MethodsWe searched PubMed, Cochrane Library, Embase databases, Clinicaltrials, and Opengrey through March 24, 2020, including references of qualifying articles. English-language, original investigations in humans about robot-assisted and laparoscopic hepatectomy were included. Titles, abstracts, and articles were reviewed by at least 2 independent readers. Continuous and dichotomous variables were compared by the weighted mean difference (WMD) and odds ratio (OR), respectively.ResultsOf 936 titles identified in our original search, 28 articles met our criteria, involving 3544 patients. Compared with laparoscopy, the robot-assisted groups had longer operative time (WMD: 36.93; 95% CI, 19.74-54.12; P < 0.001), lower conversion rate (OR: 0.63; 95% CI, 0.46-0.87; P = 0.005), higher transfusion rate (WMD: 2.39; 95% CI, 1.51-3.76; P < 0.001) and higher total cost (WMD:0.49; 95% CI, 0.42-0.55; P < 0.001). In addition, the baseline characteristics of patients about largest tumor size was larger (WMD: 0.36; 95% CI, 0.16-0.56; P < 0.001) and malignant lesions rate was higher (WMD: 1.50; 95% CI, 1.21-1.86; P < 0.001) in the robot-assisted versus laparoscopic hepatectomy. The subgroup analysis of minor hepatectomy showed robot-assisted was associated with longer operative time (WMD: 36.00; 95% CI, 12.59-59.41; P = 0.003), longer length of stay (WMD: 0.51; 95% CI, 0.02-1.01; p = 0.04) and higher total cost (WMD: 0.48; 95% CI, 0.25-0.72; P < 0.001) (Table 3); while the subgroup analysis of major hepatectomy showed robot-assisted was associated with lower estimated blood loss (WMD: -122.43; 95% CI, -151.78--93.08; P < 0.001).ConclusionsOur meta-analysis revealed that robot-assisted was associated with longer operative time, lower conversion rate, higher transfusion rate and total cost, and robot-assisted has certain advantages in major hepatectomy compared with laparoscopic hepatectomy.

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.

Dataset Information

The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets