Colorectal CancerX-CLOSURENCT07585344
Interrupted 'Figure-of-X' Versus Continuous Suturing Technique for Abdominal Wall Closure in Colorectal Laparotomies
A study testing Interrupted 'Figure-of-X' Suturing Technique and CONTINUOUS AMSS CLOSURE in people with Colorectal Cancer, run by Islamabad Medical and Dental College at 1 site in Pakistan.
Trial summary
This prospective randomized comparative study aims to evaluate whether interrupted figure-of-X fascial closure reduces the incidence of burst abdomen compared with continuous suturing in patients undergoing open colorectal laparotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Interrupted 'Figure-of-X' Suturing Technique and CONTINUOUS AMSS CLOSURE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Nov 2025to 15 May 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (aged 18 years and above).
- Patients undergoing open laparotomy for histologically confirmed colorectal cancer.
- Elective surgical procedures.
Who cannot join
- Patients with a previous midline laparotomy within the last 30 days.
- Patients in whom the abdominal wall is planned to be left open or managed with a temporary closure (open abdomen).
- Patients with known connective tissue disorders (e.g., Ehlers-Danlos syndrome) that might impair wound healing.
- Patients with an expected survival of less than 30 days.
- Emergency laparotomies.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Islamabad Medical and Dental College
Islamabad, Punjab Province, 46000
About this study
Official title: Interrupted 'Figure-of-X' Versus Continuous Suturing Technique for Abdominal Wall Closure in Colorectal Laparotomies: A Comparative Study on the Incidence of Burst Abdomen
This prospective randomized comparative study aims to evaluate whether interrupted figure-of-X fascial closure reduces the incidence of burst abdomen compared with continuous suturing in patients undergoing open colorectal laparotomy. Burst abdomen is a serious postoperative complication associated with increased morbidity, prolonged hospital stay, and reoperation.
A total of 40 adult patients undergoing elective or emergency colorectal laparotomy will be randomized into two groups: interrupted figure-of-X closure or continuous fascial closure. The primary outcome will be the incidence of burst abdomen within 30 days after surgery. Secondary outcomes will include surgical site infection, seroma, hematoma, and length of hospital stay.
The study is being conducted at the Department of General Surgery, Akbar Niazi Teaching Hospital, Islamabad, Pakistan.
Read the detailed description
Burst abdomen, also known as abdominal wound dehiscence, is a major postoperative complication following midline laparotomy. It is associated with increased postoperative morbidity, prolonged hospitalization, need for reoperation, and increased mortality. Although several abdominal wall closure techniques are currently practiced, the optimal method for preventing fascial dehiscence remains controversial.
Continuous mass closure is commonly used because of its technical simplicity and shorter operative time. However, interrupted techniques, including interrupted figure-of-X suturing, may distribute tension more evenly across the wound and potentially reduce the risk of fascial disruption. Previous randomized and observational studies have shown inconsistent results regarding superiority of one closure technique over another, particularly in high-risk abdominal surgeries.
This study aims to compare interrupted figure-of-X closure with continuous fascial closure in patients undergoing colorectal laparotomy. The study will be conducted as a prospective, randomized, single-center comparative trial at Akbar Niazi Teaching Hospital, Islamabad, Pakistan.
After informed consent and eligibility assessment, 40 adult patients undergoing elective or emergency open colorectal laparotomy will be randomized in a 1:1 ratio into two groups:
Group A: Interrupted figure-of-X fascial closure Group B: Continuous fascial closure
Randomization will be performed using computer-generated permuted blocks with allocation concealment through sealed opaque envelopes. Surgeons cannot be blinded because of the nature of the intervention; however, postoperative outcome assessors and data analysts will remain blinded to group allocation.
The abdominal fascia in both groups will be closed using slowly absorbable monofilament sutures according to a standardized operative protocol. Operative variables including suture material, bite spacing, operative duration, contamination level, and postoperative wound complications will be recorded.
The primary outcome will be incidence of burst abdomen within 30 days following surgery. Secondary outcomes will include surgical site infection, seroma formation, hematoma, reoperation, and postoperative length of hospital stay.
The findings of this study may help determine a safer and more effective abdominal wall closure technique in colorectal laparotomy patients and may contribute to improved postoperative surgical outcomes in high-risk populations.
- Conditions
- Colorectal Cancer
- Being tested
- Interrupted 'Figure-of-X' Suturing Technique, CONTINUOUS AMSS CLOSURE
- Keywords
- colorectal cancer, Figure-of-Eight, surgical wound dehiscence
- Medical subject headings
- Colorectal Neoplasms, Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interrupted 'Figure-of-X' Suturing TechniqueProcedure or surgery
For the Figure-of-X: Specify the use of a "slowly absorbable monofilament suture" with "1 cm tissue bites and 1 cm spacing" in an interrupted X-pattern.
For the Continuous closure: Specify the use of a "single-layer continuous mass closure" with the same suture material and spacing requirements
CONTINUOUS AMSS CLOSUREProcedure or surgery
The abdominal fascia is closed using a standard single- layer continuous (running) mass closure technique. A slowly absorbable monofilament suture is used to provide prolonged tensile strength. The technique follows a continuous suture line with approximately 1 cm tissue bites from the fascial edges and a 1 cm interval between each loop (travel). The suture is started at one end of the incision and continued to the other, ensuring even tension throughout the length of the midline laparotomy wound.
| Study group | Role | What they receive |
|---|---|---|
| interrupted figure of X SUTURE | Experimental | Abdominal wall closure performed using the interrupted 'Figure-of-X' suturing technique. The fascia is closed with interrupted X-shaped sutures using a slowly absorbable monofilament (PDS) or similar material. Each suture involves taking 1 cm tissue bites from the fascial edges with approximately 1 cm intervals between each 'X' to ensure secure mass closure. Receives: Procedure: Interrupted 'Figure-of-X' Suturing Technique |
| CONTINUOUS MASS CLOSURE | Active comparator | : Abdominal wall closure performed using the standard continuous (running) suturing technique. A single-layer continuous mass closure is executed using a slowly absorbable monofilament suture material. The technique involves continuous stitching with approximately 1 cm tissue bites and 1 cm intervals between each loop to ensure an even distribution of tension across the midline incision. Receives: Procedure: CONTINUOUS AMSS CLOSURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
THE INCIDENCE OF BURST ABDOMEN
The number of participants experiencing postoperative disruption of the musculo-fascial layer (complete wound dehiscence) following midline laparotomy.
Measured: UPTO 30 DAYS POST SURGERY
Secondary outcomes (3)
Incidence of Surgical Site Infection (SSI)
Occurrence of infection at the surgical site, categorized as superficial, deep, or organ/space infection according to CDC criteria.
Measured: UPTO 30DAYS POST SURGERY
Postoperative Seroma and Hematoma Formation
Outcome Measure Description: The occurrence of fluid collection (seroma) or blood collection (hematoma) within the surgical wound.
Measured: Up to 30 days post-surgery.
Length of Hospital Stay
The total number of days the participant remains in the hospital starting from the day of surgery until discharge.
Measured: From date of surgery until date of discharge (approximately 7-14 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start7 Nov 2025
- Primary completion5 Apr 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to undergo abdominal fascial closure using either interrupted figure-of-X suturing or continuous suturing following colorectal laparotomy. Outcomes will be compared between the two parallel study groups.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamabad Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585344
- Sponsor's protocol ID
- CRS-2024-135-8
- Other IDs
- 238/IMDC/IREB-2025
- Acronym
- X-CLOSURE
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant privacy and maintain the confidentiality of sensitive medical information related to colorectal cancer treatment, individual participant data (IPD) will not be made available for public sharing. Data collected for this study will be used strictly for the purposes outlined in the study protocol and will only be accessible to the research team and institutional oversight committees. Aggregate results and study outcomes will be shared through peer-reviewed publications and conference presentations.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrupted 'Figure-of-X' Versus Continuous Suturing Technique for Abdominal Wall Closure in Colorectal Laparotomies: A Comparative Study on the Incidence of Burst Abdomen
- ClinicalTrials.gov ID
- NCT07585344
- Acronym / sponsor ID
- X-CLOSURE / CRS-2024-135-8
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, Figure-of-Eight, surgical wound dehiscence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Islamabad Medical and Dental CollegeUniversity, hospital or other
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 5 Apr 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 13 May 2026 (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.
This prospective randomized comparative study aims to evaluate whether interrupted figure-of-X fascial closure reduces the incidence of burst abdomen compared with continuous suturing in patients undergoing open colorectal laparotomy. Burst abdomen is a serious postoperative complication associated with increased morbidity, prolonged hospital stay, and reoperation.
A total of 40 adult patients undergoing elective or emergency colorectal laparotomy will be randomized into two groups: interrupted figure-of-X closure or continuous fascial closure. The primary outcome will be the incidence of burst abdomen within 30 days after surgery. Secondary outcomes will include surgical site infection, seroma, hematoma, and length of hospital stay.
The study is being conducted at the Department of General Surgery, Akbar Niazi Teaching Hospital, Islamabad, Pakistan.
Detailed description
Burst abdomen, also known as abdominal wound dehiscence, is a major postoperative complication following midline laparotomy. It is associated with increased postoperative morbidity, prolonged hospitalization, need for reoperation, and increased mortality. Although several abdominal wall closure techniques are currently practiced, the optimal method for preventing fascial dehiscence remains controversial.
Continuous mass closure is commonly used because of its technical simplicity and shorter operative time. However, interrupted techniques, including interrupted figure-of-X suturing, may distribute tension more evenly across the wound and potentially reduce the risk of fascial disruption. Previous randomized and observational studies have shown inconsistent results regarding superiority of one closure technique over another, particularly in high-risk abdominal surgeries.
This study aims to compare interrupted figure-of-X closure with continuous fascial closure in patients undergoing colorectal laparotomy. The study will be conducted as a prospective, randomized, single-center comparative trial at Akbar Niazi Teaching Hospital, Islamabad, Pakistan.
After informed consent and eligibility assessment, 40 adult patients undergoing elective or emergency open colorectal laparotomy will be randomized in a 1:1 ratio into two groups:
Group A: Interrupted figure-of-X fascial closure Group B: Continuous fascial closure
Randomization will be performed using computer-generated permuted blocks with allocation concealment through sealed opaque envelopes. Surgeons cannot be blinded because of the nature of the intervention; however, postoperative outcome assessors and data analysts will remain blinded to group allocation.
The abdominal fascia in both groups will be closed using slowly absorbable monofilament sutures according to a standardized operative protocol. Operative variables including suture material, bite spacing, operative duration, contamination level, and postoperative wound complications will be recorded.
The primary outcome will be incidence of burst abdomen within 30 days following surgery. Secondary outcomes will include surgical site infection, seroma formation, hematoma, reoperation, and postoperative length of hospital stay.
The findings of this study may help determine a safer and more effective abdominal wall closure technique in colorectal laparotomy patients and may contribute to improved postoperative surgical outcomes in high-risk populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to undergo abdominal fascial closure using either interrupted figure-of-X suturing or continuous suturing following colorectal laparotomy. Outcomes will be compared between the two parallel study groups.
| Arm | Type | Receives |
|---|---|---|
| interrupted figure of X SUTURE | Experimental | Procedure: Interrupted 'Figure-of-X' Suturing TechniqueAbdominal wall closure performed using the interrupted 'Figure-of-X' suturing technique. The fascia is closed with interrupted X-shaped sutures using a slowly absorbable monofilament (PDS) or similar material. Each suture involves taking 1 cm tissue bites from the fascial edges with approximately 1 cm intervals between each 'X' to ensure secure mass closure. |
| CONTINUOUS MASS CLOSURE | Active comparator | Procedure: CONTINUOUS AMSS CLOSURE: Abdominal wall closure performed using the standard continuous (running) suturing technique. A single-layer continuous mass closure is executed using a slowly absorbable monofilament suture material. The technique involves continuous stitching with approximately 1 cm tissue bites and 1 cm intervals between each loop to ensure an even distribution of tension across the midline incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (aged 18 years and above).
- Patients undergoing open laparotomy for histologically confirmed colorectal cancer.
- Elective surgical procedures.
Key exclusion criteria (5 listed)
- Patients with a previous midline laparotomy within the last 30 days.
- Patients in whom the abdominal wall is planned to be left open or managed with a temporary closure (open abdomen).
- Patients with known connective tissue disorders (e.g., Ehlers-Danlos syndrome) that might impair wound healing.
- Patients with an expected survival of less than 30 days.
- Emergency laparotomies.
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 |
|---|---|---|
| Interrupted 'Figure-of-X' Suturing TechniqueFor the Figure-of-X: Specify the use of a "slowly absorbable monofilament suture" with "1 cm tissue bites and 1 cm spacing" in an interrupted X-pattern. For the Continuous closure: Specify the use of a "single-layer continuous mass closure" with the same suture material and spacing requirements | Procedure or surgery | interrupted figure of X SUTURE |
| CONTINUOUS AMSS CLOSUREThe abdominal fascia is closed using a standard single- layer continuous (running) mass closure technique. A slowly absorbable monofilament suture is used to provide prolonged tensile strength. The technique follows a continuous suture line with approximately 1 cm tissue bites from the fascial edges and a 1 cm interval between each loop (travel). The suture is started at one end of the incision and continued to the other, ensuring even tension throughout the length of the midline laparotomy wound. | Procedure or surgery | CONTINUOUS MASS CLOSURE |
Primary outcome
THE INCIDENCE OF BURST ABDOMEN
Time frame: UPTO 30 DAYS POST SURGERY
The number of participants experiencing postoperative disruption of the musculo-fascial layer (complete wound dehiscence) following midline laparotomy.
3 secondary outcomes
Incidence of Surgical Site Infection (SSI)
Time frame: UPTO 30DAYS POST SURGERY
Postoperative Seroma and Hematoma Formation
Time frame: Up to 30 days post-surgery.
Length of Hospital Stay
Time frame: From date of surgery until date of discharge (approximately 7-14 days).
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 26 May 2026.
- Islamabad Medical and Dental College - Institutional Review Board (IRB) home page.Link provided by the sponsor.
- Individual participant dataSharing planned: No. To protect participant privacy and maintain the confidentiality of sensitive medical information related to colorectal cancer treatment, individual participant data (IPD) will not be made available for public sharing. Data collected for this study will be used strictly for the purposes outlined in the study protocol and will only be accessible to the research team and institutional oversight committees. Aggregate results and study outcomes will be shared through peer-reviewed publications and conference presentations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interrupted 'Figure-of-X' Suturing Technique and CONTINUOUS AMSS CLOSURE in people with Colorectal Cancer, run by Islamabad Medical and Dental College at 1 site in Pakistan.
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 3 inclusion and 5 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 26 May 2026. 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 Pakistan. 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?
THE INCIDENCE OF BURST ABDOMEN (time frame: UPTO 30 DAYS POST SURGERY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2026.