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Clinical Trials/NCT05622110
NCT05622110CompletedNot Applicable

Laparoscopic Incision Closure Following Gynecological Benign Surgeries in Obese Patients

The University of Texas Health Science Center, Houston2 sites in 1 country53 target enrollmentStarted: December 2, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
53
Locations
2
Primary Endpoint
Patient Scar Assessment Questionnaire (PSAQ)

Study Overview

Brief Summary

Several methods for closure of trocar wounds are known in laparoscopic surgery including mostly transcutaneous or subcuticular suture or adhesive paper tape. Studies comparing laparoscopic incision closure in bariatric population are limited .This is a prospective study that will be conducted in a single tertiary medical center. s obese population comprise most of our surgical candidates, and due to the aforementioned, the aim of our study is to compare the outcomes of both techniques in obese women.

Detailed Description

Laparoscopic surgery has become the standard of care for surgical procedures across multiple specialties, reducing perioperative complications, accelerating recovery and providing superior cosmetic results. Trocars are used in laparoscopic procedures to provide a portal for the placement of surgical instruments. Typically, three to four or more trocars of different sizes ranging from 5 to 15 mm in diameter are used in abdominal and pelvic surgery.

Several methods for closure of trocar wounds are known in laparoscopic surgery including mostly transcutaneous or subcuticular suture or adhesive paper tape. The skin closure method should aim to keep the skin closely opposed during the hemostatic and inflammatory healing phases until the overlapping proliferative phase is able to provide tensile strength. The choice of technique is often based on the surgeon's personal experience. and is largely dependent on training exposure and local opinion. There is currently no consensus as to the optimal method of closure of the skin following laparoscopic surgery.

Previous meta-analyses examining skin closure methods for all surgical wounds have found suture to have significantly decreased rates of wound dehiscence compared to tissue adhesive. Meta-analysis published recently by Aitchison et al. compared between sutures, tissue adhesives and adhesive paper tape. They reported no difference in patient-evaluated cosmesis, prolonged pain, or patient satisfaction between the three groups. Nevertheless, no data specifically address the obese population.

Port-site trocar incision closure is a challenging procedure in laparoscopic surgeries, particularly in patients with clinically severe (morbid) obesity. Complications related to port-site trocars, even if uncommon, may have severe consequences that can lead to reoperation and permanent damage Studies comparing laparoscopic incision closure in bariatric population are limited. Fecso et al conducted a retrospective cohort study including 1579 bariatric patients, of them 494 were treated with tissue adhesive for skin closure. They reported that the use of tissue adhesive was more common in patients who developed incisional surgical site infection compared with those without incisional surgical site infection (SSI) (54.3 vs. 30.8%, p = 0.003).

Our department usually practice subcuticular and adhesive glue for the closure of laparoscopic incisions, based on surgeon's preference. As obese population comprise most of our surgical candidates, and due to the aforementioned, the aim of our study is to compare the outcomes of both techniques in obese women.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Care Provider)

Masking Description

The physician doing follow up will be masked to the type of closure in each side

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • All women undergoing gynecologic laparoscopic surgery.

Exclusion Criteria

  • Connective tissue disease

Outcomes

Primary Outcomes

Patient Scar Assessment Questionnaire (PSAQ)

Time Frame: From recruitment until 8 weeks post-operation

The difference in appearance score of the abdominal scars evaluated by the Patient Scar Assessment Questionnaire (PSAQ) between the two techniques reported by the patients at 2 and 8 weeks follow up

Secondary Outcomes

  • Surgical site infection rate(From recruitment until 8 weeks post-operation)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aya Mohr Sasson

Principle investigator

The University of Texas Health Science Center, Houston

Study Sites (2)

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