Duodenal PerforationNCT05632146
COMPARISON OF CONTINUOUS VERSUS INTERRUPTED-X SUTURING TECHNIQUE FOR CLOSURE OF RECTUS SHEATH IN PATIENTS UNDERGOING EMERGENCY LAPAROTOMY FOR HOLLOW VISCUS PERFORATION
A study testing Continuous suturing and Interrupted X suturing in people with Duodenal Perforation and Bowel Perforated, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
THIS STUDY IS GOING TO COMPARE THE INCIDENCE OF BURST ABDOMEN IN PATIENTS UNDERGOING LAPAROTOMY WOUND CLOSURE IN CONTINUOUS VERSUS INTERRRUPTED-X MANNER Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Duodenal Perforation, Bowel Perforated
- What is being tested?
- Continuous suturing and Interrupted X suturing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jun 2022to 3 Nov 2023
- 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
- All patients of both genders with age greater than 18 years, undergoing emergency laparotomy through midline incision for hollow viscus perforation.
- ASA grade III
Who cannot join
- Patients who had undergone a previous laparotomy for any condition or had an incisional hernia or burst abdomen at presentation.
- Patients undergoing laparotomy with anterior abdominal wall injury in the form of muscle hematoma, disruption or abdominal wall laceration.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
King Edward Medical University / Mayo Hospital
Lahore, Punjab Province, 54000
3228420433, mzeeshansarwar@kemu.edu.pk
About this study
THIS STUDY IS GOING TO COMPARE THE INCIDENCE OF BURST ABDOMEN IN PATIENTS UNDERGOING LAPAROTOMY WOUND CLOSURE IN CONTINUOUS VERSUS INTERRRUPTED-X MANNER
Read the detailed description
An emergency laparotomy is a common surgical procedure, performed for a wide variety of intra-abdominal pathologies, which has a significant associated morbidity and mortality. Each year, approximately 30,000 emergency laparotomies are performed in the UK [1]. A major surgical complication after emergency midline laparotomy is abdominal fascial dehiscence. Dehiscence is associated with increased morbidity and mortality rates up to 30%, prolonged hospital stay, and a long-term risk of developing incisional hernia [1].
Hollow viscus perforation is one of the most common cause of peritonitis necessitating emergency surgical intervention. The diagnosis is mainly based on clinical grounds. Plain abdominal X-rays (erect) may reveal dilated and edematous intestines with pneumoperitoneum. Local findings include abdominal tenderness, guarding or rigidity, distension, diminished bowel sounds and systemic findings include fever, chills or rigor, tachycardia, sweating, tachypnea, restlessness, dehydration, oliguria, disorientation and ultimately shock. Exposure of the normally sterile peritoneal cavity to intraluminal contents causes secondary bacterial peritonitis. The peritoneal contamination due to bowel perforation is one of the leading risk factor for occurrence of burst abdomen [2].
Laparotomy wound dehiscence (LWD) is a term used to describe separation of the layers of a laparotomy wound before complete healing has taken place. Other terms used interchangeably are acute laparotomy wound failure and burst abdomen. Frequency of laparotomy wound dehiscence in the relevant literature is cited in the range of 0.2% to 10%[3,4]. The occurrence of fascial dehiscence represents a risk factor for increased mortality rates of up to 25%[5] Acute wound failure may be occult or overt, partial or complete. Overt wound failure follows early removal of sutures leading to evisceration. Occult dehiscence occurs with disruption of musculo-aponeurotic layer beneath intact skin sutures. Wound dehiscence has been noted to occur when a wound fails to gain sufficient strength to withstand stresses placed upon it. The separation may occur when overwhelming forces break sutures, when absorbable sutures dissolve too quickly or when tight sutures cut through tissues [6].
Conventional continuous closure technique has been shown to compromise blood supply and thereby poor wound holding, during initial phases of wound dehiscence. Surgeons have been continuously striving to overcome postoperative complications associated with laparotomy wound closure using newer techniques and newer suture materials. Several reviews have studied the optimal suture repair for closing the abdominal fascia, but no consensus has been reached. Hence, it is imperative for us to ascertain better method of closing the abdomen. While the choice may not be so important in elective patients who are nutritionally adequate, do not have any risk factor for dehiscence and are well prepared for surgery, however it may prove crucial in emergency patients who often have multiple risk factors for developing dehiscence and the strangulation of the sheath is the proverbial last straw in precipitating wound failure [7].
A number of studies have been conducted which suggest that new interrupted X-technique for abdominal closure after midline laparotomy significantly reduces the risk of burst abdomen [8,9]. A study done by Balaji C et al comparing continuous versus interrupted X suture technique showed that incidence of wound dehiscence was 10 % in patients who underwent interrupted X closure and 36% in patients who underwent continuous closure [10]. However, these studies haven't taken into account a specific study population with similar pathology and risk of burst abdomen to compare the two suturing techniques. So, the aim of the present study is to compare the prevalence of burst abdomen in patients undergoing midline abdominal wall closure with interrupted X-suturing technique and continuous suturing technique in patients with enteric perforation.
- Conditions
- Duodenal Perforation, Bowel Perforated
- Being tested
- Continuous suturing, Interrupted X suturing
- Medical subject headings
- Intestinal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous suturingProcedure or surgery
In continuous closure, each bite will be taken 2 cm from the cut edge of linea alba and successive bites taken 1 cm from each other in continuous fashion followed by gentle approximation of the wound
Interrupted X suturingProcedure or surgery
In interrupted X closure, large bite will be taken outside-in, 2 cm from the cut edge of linea alba and the needle emerged on the other side from inside out diagonally 2 cm from the edge and 4 cm below the first bite and this strand will be crossed and continued outside-in, diagonally at 90 degree to the first diagonal. The two ends will be tied just tight enough to approximate the edges of linea alba.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hollow viscus perforation | Active comparator | Not described Receives: Procedure: Continuous suturing; Procedure: Interrupted X suturing |
| Patient with hollow viscus perforation | Active comparator | Not described Receives: Procedure: Continuous suturing; Procedure: Interrupted X suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burst abdomen
It is defined as partial or complete separation of the abdominal musculo-aponeurotic layer leading to protrusion or evisceration of abdominal contents.
Measured: 1-14 days
Secondary outcomes (3)
Pain score
Pain score will be assessed post-operatively using visual analogue score ranging from 0 to 10 with 0 being no pain and 10 being the worst pain
Measured: 1-14 days
Superficial surgical site infection
Pain, tenderness, localized swelling, erythema at wound site and surgeon open up the superficial incision, revealing purulent discharge and confirmation of pathogen on culture grown from aseptically harvested wound discharge.
Measured: 1-14 days
Deep surgical site infection
Infection within peritoneal cavity presenting with purulent discharge from a drain with pathogen confirmed on culture or abdominal collection documented on USG will be labelled as deep surgical site infection.
Measured: 1-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start2 Jun 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion3 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal PerforationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632146
- Sponsor's protocol ID
- KingEdwardMU1
- Status last verified
- Nov 2022
- First submitted
- 20 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF CONTINUOUS VERSUS INTERRUPTED-X SUTURING TECHNIQUE FOR CLOSURE OF RECTUS SHEATH IN PATIENTS UNDERGOING EMERGENCY LAPAROTOMY FOR HOLLOW VISCUS PERFORATION
- ClinicalTrials.gov ID
- NCT05632146
- Acronym / sponsor ID
- KingEdwardMU1
- Conditions
- Duodenal Perforation, Bowel Perforated
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 3 Nov 2023 (estimated)
- First posted
- 30 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.
THIS STUDY IS GOING TO COMPARE THE INCIDENCE OF BURST ABDOMEN IN PATIENTS UNDERGOING LAPAROTOMY WOUND CLOSURE IN CONTINUOUS VERSUS INTERRRUPTED-X MANNER
Detailed description
An emergency laparotomy is a common surgical procedure, performed for a wide variety of intra-abdominal pathologies, which has a significant associated morbidity and mortality. Each year, approximately 30,000 emergency laparotomies are performed in the UK [1]. A major surgical complication after emergency midline laparotomy is abdominal fascial dehiscence. Dehiscence is associated with increased morbidity and mortality rates up to 30%, prolonged hospital stay, and a long-term risk of developing incisional hernia [1].
Hollow viscus perforation is one of the most common cause of peritonitis necessitating emergency surgical intervention. The diagnosis is mainly based on clinical grounds. Plain abdominal X-rays (erect) may reveal dilated and edematous intestines with pneumoperitoneum. Local findings include abdominal tenderness, guarding or rigidity, distension, diminished bowel sounds and systemic findings include fever, chills or rigor, tachycardia, sweating, tachypnea, restlessness, dehydration, oliguria, disorientation and ultimately shock. Exposure of the normally sterile peritoneal cavity to intraluminal contents causes secondary bacterial peritonitis. The peritoneal contamination due to bowel perforation is one of the leading risk factor for occurrence of burst abdomen [2].
Laparotomy wound dehiscence (LWD) is a term used to describe separation of the layers of a laparotomy wound before complete healing has taken place. Other terms used interchangeably are acute laparotomy wound failure and burst abdomen. Frequency of laparotomy wound dehiscence in the relevant literature is cited in the range of 0.2% to 10%[3,4]. The occurrence of fascial dehiscence represents a risk factor for increased mortality rates of up to 25%[5] Acute wound failure may be occult or overt, partial or complete. Overt wound failure follows early removal of sutures leading to evisceration. Occult dehiscence occurs with disruption of musculo-aponeurotic layer beneath intact skin sutures. Wound dehiscence has been noted to occur when a wound fails to gain sufficient strength to withstand stresses placed upon it. The separation may occur when overwhelming forces break sutures, when absorbable sutures dissolve too quickly or when tight sutures cut through tissues [6].
Conventional continuous closure technique has been shown to compromise blood supply and thereby poor wound holding, during initial phases of wound dehiscence. Surgeons have been continuously striving to overcome postoperative complications associated with laparotomy wound closure using newer techniques and newer suture materials. Several reviews have studied the optimal suture repair for closing the abdominal fascia, but no consensus has been reached. Hence, it is imperative for us to ascertain better method of closing the abdomen. While the choice may not be so important in elective patients who are nutritionally adequate, do not have any risk factor for dehiscence and are well prepared for surgery, however it may prove crucial in emergency patients who often have multiple risk factors for developing dehiscence and the strangulation of the sheath is the proverbial last straw in precipitating wound failure [7].
A number of studies have been conducted which suggest that new interrupted X-technique for abdominal closure after midline laparotomy significantly reduces the risk of burst abdomen [8,9]. A study done by Balaji C et al comparing continuous versus interrupted X suture technique showed that incidence of wound dehiscence was 10 % in patients who underwent interrupted X closure and 36% in patients who underwent continuous closure [10]. However, these studies haven't taken into account a specific study population with similar pathology and risk of burst abdomen to compare the two suturing techniques. So, the aim of the present study is to compare the prevalence of burst abdomen in patients undergoing midline abdominal wall closure with interrupted X-suturing technique and continuous suturing technique in patients with enteric perforation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with hollow viscus perforation | Active comparator | Procedure: Continuous suturing, Procedure: Interrupted X suturing |
| Patient with hollow viscus perforation | Active comparator | Procedure: Continuous suturing, Procedure: Interrupted X suturing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients of both genders with age greater than 18 years, undergoing emergency laparotomy through midline incision for hollow viscus perforation.
- ASA grade III
Key exclusion criteria (2 listed)
- Patients who had undergone a previous laparotomy for any condition or had an incisional hernia or burst abdomen at presentation.
- Patients undergoing laparotomy with anterior abdominal wall injury in the form of muscle hematoma, disruption or abdominal wall laceration.
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 |
|---|---|---|
| Continuous suturingIn continuous closure, each bite will be taken 2 cm from the cut edge of linea alba and successive bites taken 1 cm from each other in continuous fashion followed by gentle approximation of the wound | Procedure or surgery | Patient with hollow viscus perforation, Patients with hollow viscus perforation |
| Interrupted X suturingIn interrupted X closure, large bite will be taken outside-in, 2 cm from the cut edge of linea alba and the needle emerged on the other side from inside out diagonally 2 cm from the edge and 4 cm below the first bite and this strand will be crossed and continued outside-in, diagonally at 90 degree to the first diagonal. The two ends will be tied just tight enough to approximate the edges of linea alba. | Procedure or surgery | Patient with hollow viscus perforation, Patients with hollow viscus perforation |
Primary outcome
Burst abdomen
Time frame: 1-14 days
It is defined as partial or complete separation of the abdominal musculo-aponeurotic layer leading to protrusion or evisceration of abdominal contents.
3 secondary outcomes
Pain score
Time frame: 1-14 days
Superficial surgical site infection
Time frame: 1-14 days
Deep surgical site infection
Time frame: 1-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous suturing and Interrupted X suturing in people with Duodenal Perforation and Bowel Perforated, run by King Edward Medical University 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeeshan Sarwar, FCPS General Surgery (3228420433 ext. +92, mzeeshansarwar@kemu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burst abdomen (time frame: 1-14 days). 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 30 Nov 2022.