Dataset Information

Post-operative pain after laparoscopic ventral hernia repair, the impact of mesh soakage with bupivacaine solution versus normal saline solution: A randomised controlled trial (HAPPIEST Trial).

ABSTRACT: Background and Aims:Early postoperative pain after laparoscopic ventral hernia repair remains a concern for patients. Local application of anaesthetic agent in the surgical dissection area can potentially overcome this problem. The objective of this study was to evaluate the impact of soaking mesh in 0.5% bupivacaine solution as compared to normal saline solution on the post-operative pain. Methodology:We conducted a parallel-design double-blind randomised controlled trial. Adult patients with uncomplicated ventral abdominal wall hernias were included in the trial. Mesh was soaked in 0.5% solution of bupivacaine before application in patients in the intervention arm, whereas it was soaked in normal saline solution for patients in the control arm. Post-operative pain was assessed by trained staff at 6 h and 24 h from surgery. It was graded on visual analogue scale (VAS) from 0 to 10. Results:Trial was conducted from 16 November, 2015, to 15 September, 2017. During the study period, a total of 114 patients were randomised. Nine patients were excluded after randomisation. A total of 55 patients were analysed in the intervention arm and 50 patients were analysed in the control arm. Mean pain score at VAS at 6 h after laparoscopic ventral hernia repair in the intervention arm was 5.05 ± 1.2, whereas in the control arm, it was 5.54 ± 1.1 and the difference was statistically significant (P = 0.03-independent sample t-test). Mean pain score at VAS at 24 h after laparoscopic ventral hernia repair in the intervention arm was 3.16 ± 1.2, whereas in the control arm, it was 3.58 ± 1.4 and the difference was not statistically significant (P = 0.11-independent sample t-test). Conclusion:Soakage of mesh in 0.5% bupivacaine solution before application in laparoscopic ventral hernia repair significantly reduces early post-operative pain. Trial Registration:Trial was registered with clinicaltrials. gov (NCT03035617)URL: https://clinicaltrials. gov.

SUBMITTER: Chawla T

PROVIDER: S-EPMC7597881 | biostudies-literature | 2020 Oct-Dec

REPOSITORIES: biostudies-literature

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Post-operative pain after laparoscopic ventral hernia repair, the impact of mesh soakage with bupivacaine solution versus normal saline solution: A randomised controlled trial (HAPPIEST Trial).

Chawla Tabish T Shahzad Noman N Ahmad Khabir K Ali Jehangir Farman JF

Journal of minimal access surgery 20201001 4

<h4>Background and aims</h4>Early postoperative pain after laparoscopic ventral hernia repair remains a concern for patients. Local application of anaesthetic agent in the surgical dissection area can potentially overcome this problem. The objective of this study was to evaluate the impact of soaking mesh in 0.5% bupivacaine solution as compared to normal saline solution on the post-operative pain.<h4>Methodology</h4>We conducted a parallel-design double-blind randomised controlled trial. Adult ...[more]

PMID: 32978352

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Project description:ImportanceDespite rapid adoption of the robotic platform for ventral hernia repair with intraperitoneal mesh in the United States, there is no level I evidence comparing it with the traditional laparoscopic approach. This randomized clinical trial sought to demonstrate a clinical benefit to the robotic approach.ObjectiveTo determine whether robotic approach to ventral hernia repair with intraperitoneal mesh would result in less postoperative pain.Design, setting, and participantsA registry-based, single-blinded, prospective randomized clinical trial at the Cleveland Clinic Center for Abdominal Core Health, Cleveland, Ohio, completed between September 2017 and January 2020, with a minimum follow-up duration of 30 days. Two surgeons at 1 academic tertiary care hospital. Patients with primary or incisional midline ventral hernias of an anticipated width of 7 cm or less presenting in the elective setting and able to tolerate a minimally invasive repair.InterventionsPatients were randomized to a standardized laparoscopic or robotic ventral hernia repair with fascial closure and intraperitoneal mesh.Main outcomes and measuresThe trial was powered to detect a 30% difference in the Numerical Rating Scale (NRS-11) on the first postoperative day. Secondary end points included the Patient-Reported Outcomes Measurement Information System Pain Intensity short form (3a), hernia-specific quality of life, operative time, wound morbidity, recurrence, length of stay, and cost.ResultsSeventy-five patients completed their minimally invasive hernia repair: 36 laparoscopic and 39 robotic. Baseline demographics and hernia characteristics were comparable. Robotic operations had a longer median operative time (146 vs 94 minutes; P < .001). There were 2 visceral injuries in each cohort but no full-thickness enterotomies or unplanned reoperations. There were no significant differences in NRS-11 scores preoperatively or on postoperative days 0, 1, 7, or 30. Specifically, median NRS-11 scores on the first postoperative day were the same (5 vs 5; P = .61). Likewise, postoperative Patient-Reported Outcomes Measurement Information System 3a and hernia-specific quality-of-life scores, as well as length of stay and complication rates, were similar. The robotic platform adds cost (total cost ratio, 1.13 vs 0.97; P = .03), driven by the cost of additional operating room time (1.25 vs 0.85; P < .001).Conclusions and relevanceLaparoscopic and robotic ventral hernia repair with intraperitoneal mesh have comparable outcomes. The increased operative time and proportional cost of the robotic approach are not offset by a measurable clinical benefit.Trial registrationClinicalTrials.gov Identifier: NCT03283982.

Project description:ObjectiveTo determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair.DesignPragmatic, blinded randomized controlled trial.SettingMultidisciplinary hernia clinics in Houston, USA.Participants124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019.InterventionsRobotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59).Main outcome measuresThe primary outcome was number of days in hospital within 90 days after surgery. Secondary outcomes included emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective. Outcomes were pre-specified before data collection began and analyzed as intention to treat.ResultsPatients from both groups were similar at baseline. Ninety day follow-up was completed in 123 (99%) patients. No evidence was seen of a difference in days in hospital between the two groups (median 0 v 0 days; relative rate 0.90, 95% confidence interval 0.37 to 2.19; P=0.82). For secondary outcomes, no differences were noted in emergency department visits, wound complications, hernia recurrence, or reoperation. However, robotic repair had longer operative duration (141 v 77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125) v $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004). Among patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair. The median one month postoperative improvement in abdominal wall quality of life was 3 with robotic ventral hernia repair compared with 15 following laparoscopic repair.ConclusionThis study found no evidence of a difference in 90 day postoperative hospital days between robotic and laparoscopic ventral hernia repair. However, robotic repair increased operative duration and healthcare costs.Trial registrationClinicaltrials.gov NCT03490266.

Project description:BackgroundThis prospective, multicenter, single-arm, open-label study evaluated P4HB-ST mesh in laparoscopic ventral or incisional hernia repair (LVIHR) in patients with Class I (clean) wounds at high risk for Surgical Site Occurrence (SSO).MethodsPrimary endpoint was SSO requiring intervention <45 days. Secondary endpoints included: surgical procedure time, length of stay, SSO >45 days, hernia recurrence, device-related adverse events, reoperation, and Quality of Life at 1, 3, 6, 12, 18, and 24-months.Results120 patients (52.5% male), mean age of 55.0 ± 14.9 years, and BMI of 33.2 ± 4.5 kg/m2 received P4HB-ST mesh. Patient-reported comorbid conditions included: obesity (86.7%), active smoker (45.0%), COPD (5.0%), diabetes (16.7%), immunosuppression (2.5%), coronary artery disease (7.5%), chronic corticosteroid use (2.5%), hypoalbuminemia (0.8%), advanced age (10.0%), and renal insufficiency (0.8%). Hernia types were primary ventral (44.2%), primary incisional (37.5%), recurrent ventral (5.8%), and recurrent incisional (12.5%). Patients underwent LVIHR in laparoscopic (55.8%) or robotic-assisted cases (44.2%), mean defect size 15.7 ± 28.3 cm2, mean procedure time 85.9 ± 43.0 min, and mean length of stay 1.0 ± 1.4 days. There were no SSOs requiring intervention beyond 45 days, n = 38 (31.7%) recurrences, n = 22 (18.3%) reoperations, and n = 2 (1.7%) device-related adverse events (excluding recurrence).ConclusionP4HB-ST mesh demonstrated low rates of SSO and device-related complications, with improved quality of life scores, and reoperation rate comparable to other published studies. Recurrence rate was higher than expected at 31.7%. However, when analyzed by hernia defect size, recurrence was disproportionately high in defects ≥7.1 cm2 (43.3%) compared to defects <7.1 cm2 (18.6%). Thus, in LVIHR, P4HB-ST may be better suited for small defects. Caution is warranted when utilizing P4HB-ST in laparoscopic IPOM repair of larger defects until additional studies can further investigate outcomes.

Dataset Information

Post-operative pain after laparoscopic ventral hernia repair, the impact of mesh soakage with bupivacaine solution versus normal saline solution: A randomised controlled trial (HAPPIEST Trial).

Publications

Post-operative pain after laparoscopic ventral hernia repair, the impact of mesh soakage with bupivacaine solution versus normal saline solution: A randomised controlled trial (HAPPIEST Trial).

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