AzTrials
AzTrials

ObesityLICOPNCT05622110

Laparoscopic Incision Closure s in Obese Patients

A study testing Adhesive glue closure and Subcuticular closure in people with Obesity and Incision, Surgical, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Incision, Surgical
What is being tested?
Adhesive glue closure and Subcuticular closure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteUnited States
Study dates
2 Dec 2023to 1 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All women undergoing gynecologic laparoscopic surgery.

Who cannot join

  • Connective tissue disease

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Texas

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Laparoscopic Incision Closure Following Gynecological Benign Surgeries in Obese Patients

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.

Read the 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.

Material and Methods This is a prospective study that will be conducted in a single tertiary medical center. Study population will include all women undergoing gynecologic laparoscopic surgery with BMI of 30 kg/m² or above. Women with connective tissue disease will be excluded from the study.

Intervention:

  1. Each woman will undergo both interventions therefore will serve as her own control. All ports up to 8 mm (following robotic or conventional laparoscopy) will be eligible for inclusion in the study. The umbilicus will serve as a reference separating the right and left side incisions. Each side will be closed randomly using one of the two techniques. Randomizing the closure technique will be done based on the serial number given to each woman on recruitment (En block randomization) : Odd serial number: Right side - subcuticular suturing, Left side- adhesive glue Even numbers: Right side- adhesive glue, Left side- subcuticular suturing
  2. Incisions would be closed by one or the other following techniques: 1- Subcuticular closure- using 4-0 Monocryl suture will be used; 2- Adhesive glue (Dermabond).
  3. On follow up visit 2- and 8-weeks post operation - each woman will complete the validated Patient Scar Assessment Questionnaire (PSAQ) on follow-up at 2- and 8-weeks post operation for the right and left side of the abdomen(10). The PSAQ consists of 4 scored subscales: Appearance, Consciousness, Appearance Satisfaction, and Symptom Satisfaction. Each subscale has a set of questions with a 4-point categorical response (1=most favorable, 4=least favorable). The sum of the scores quantifies each subscale.

Demographic and clinical characteristics will be collected from women's medical files. Operative and post-operative data will be collected including: operation duration, estimated blood loss, operation complications (hypotension, bladder gut or vascular perforation), post-operative complications (hemorrhage, endometritis, vascular - thromboembolic event, ileus).

Being tested
Adhesive glue closure, Subcuticular closure
Medical subject headings
Obesity, Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adhesive glue closureProcedure or surgery

    Incision closure with adhesive glue

  • Subcuticular closureProcedure or surgery

    Incision closure with 3-0 vicryl subcuticular sutures

Study groups in NCT05622110
Study groupRoleWhat they receive
One abdominal sideExperimentalArm randomized for adhesive glue closure
Receives: Procedure: Adhesive glue closure
Second abdominal sideExperimentalArm randomized for subcuticular suture closure
Receives: Procedure: Subcuticular closure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Scar Assessment Questionnaire (PSAQ)

    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

    Measured: From recruitment until 8 weeks post-operation

Secondary outcomes (1)
  1. Surgical site infection rate

    Surgical site infection rate

    Measured: From recruitment until 8 weeks post-operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2022
  2. Study start2 Dec 2023
  3. Primary completion1 Dec 2024
  4. Study completion1 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05622110
Sponsor's protocol ID
HSC-MS-22-0840
Acronym
LICOP
Status last verified
Apr 2025
First submitted
10 Nov 2022
Last updated
8 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Andraos Y. Safety and Efficacy of Trocar Port-Site Closure Using a Biological Plug Closure in Laparoscopic Bariatric Surgery: a Prospective Study. Obes Surg. 2022 Nov;32(11):3796-3806. doi: 10.1007/s11695-022-06238-y. Epub 2022 Sep 7.

    PubMed 36071329
  • Pilone V, Di Micco R, Hasani A, Celentano G, Monda A, Vitiello A, Izzo G, Iacobelli L, Forestieri P. Trocar site hernia after bariatric surgery: our experience without fascial closure. Int J Surg. 2014;12 Suppl 1:S83-6. doi: 10.1016/j.ijsu.2014.05.047. Epub 2014 May 23.

    PubMed 24862661
  • Harvey MH, Cahill J, Wastell C. Laparoscopic general surgery. Br J Hosp Med. 1992 May 6-19;47(9):655-62.

    PubMed 1535528
  • Qian LW, Fourcaudot AB, Yamane K, You T, Chan RK, Leung KP. Exacerbated and prolonged inflammation impairs wound healing and increases scarring. Wound Repair Regen. 2016 Jan-Feb;24(1):26-34. doi: 10.1111/wrr.12381. Epub 2016 Jan 12.

    PubMed 26562746
  • Buchweitz O, Wulfing P, Kiesel L. A prospective randomized trial of closing laparoscopic trocar wounds by transcutaneous versus subcuticular suture or adhesive papertape. Surg Endosc. 2005 Jan;19(1):148-51. doi: 10.1007/s00464-004-9043-2. Epub 2004 Nov 18.

    PubMed 15549624
  • Sajid MS, Siddiqui MR, Khan MA, Baig MK. Meta-analysis of skin adhesives versus sutures in closure of laparoscopic port-site wounds. Surg Endosc. 2009 Jun;23(6):1191-7. doi: 10.1007/s00464-009-0373-y. Epub 2009 Mar 5.

    PubMed 19263132
  • Dumville JC, Coulthard P, Worthington HV, Riley P, Patel N, Darcey J, Esposito M, van der Elst M, van Waes OJ. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD004287. doi: 10.1002/14651858.CD004287.pub4.

    PubMed 25431843
  • Aitchison LP, Chen AZL, Toms C, Sandroussi C, Yeo DA, Steffens D. To stitch or not to stitch: the skin closure of laparoscopic port sites, a meta-analysis. Surg Endosc. 2022 Oct;36(10):7140-7159. doi: 10.1007/s00464-022-09269-9. Epub 2022 May 24.

    PubMed 35610480

Questions about this trial

What is this clinical trial studying?

A study testing Adhesive glue closure and Subcuticular closure in people with Obesity and Incision, Surgical, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Scar Assessment Questionnaire (PSAQ) (time frame: From recruitment until 8 weeks post-operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05622110, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in