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.
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.
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:
- 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
- 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).
- 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).
- Conditions
- Obesity, Incision, Surgical
- 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 group | Role | What they receive |
|---|---|---|
| One abdominal side | Experimental | Arm randomized for adhesive glue closure Receives: Procedure: Adhesive glue closure |
| Second abdominal side | Experimental | Arm 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.
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)
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.
- First posted18 Nov 2022
- Study start2 Dec 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohr Sasson, The University of Texas Health Science Center, Houston
- Investigators
- Aya Mohr-Sasson, M.D, Principal investigator, The University of Texas Health Science Center, Houston, TX
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 36071329Pilone 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 24862661Harvey MH, Cahill J, Wastell C. Laparoscopic general surgery. Br J Hosp Med. 1992 May 6-19;47(9):655-62.
PubMed 1535528Qian 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 26562746Buchweitz 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 15549624Sajid 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 19263132Dumville 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 25431843Aitchison 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Incision Closure Following Gynecological Benign Surgeries in Obese Patients
- ClinicalTrials.gov ID
- NCT05622110
- Acronym / sponsor ID
- LICOP / HSC-MS-22-0840
- Conditions
- Obesity, Incision, Surgical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
- 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).
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One abdominal side | Experimental | Procedure: Adhesive glue closureArm randomized for adhesive glue closure |
| Second abdominal side | Experimental | Procedure: Subcuticular closureArm randomized for subcuticular suture closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women undergoing gynecologic laparoscopic surgery.
Key exclusion criteria (1 listed)
- Connective tissue disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adhesive glue closureIncision closure with adhesive glue | Procedure or surgery | One abdominal side |
| Subcuticular closureIncision closure with 3-0 vicryl subcuticular sutures | Procedure or surgery | Second abdominal side |
Primary outcome
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
1 secondary outcome
Surgical site infection rate
Time frame: From recruitment until 8 weeks post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Background: PubMed 36071329Andraos 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.
- Background: PubMed 24862661Pilone 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.
- Results publication: PubMed 1535528Harvey MH, Cahill J, Wastell C. Laparoscopic general surgery. Br J Hosp Med. 1992 May 6-19;47(9):655-62.
- Results publication: PubMed 26562746Qian 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.
- Results publication: PubMed 15549624Buchweitz 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.
- Results publication: PubMed 19263132Sajid 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.
- Results publication: PubMed 25431843Dumville 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.
- Results publication: PubMed 35610480Aitchison 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aya Mohr-Sasson, M.D principal investigator
The University of Texas Health Science Center, Houston, TX
1 site in 1 country: see every site and its status.
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.