Midline LaparotomyNCT05199974
Comparison Between Conventional and Modified Smead Jones Method for Mass Closure in Emergency Midline Laparotomy
A study testing Midline abdominal closure in people with Midline Laparotomy, run by Sohag University at 1 site in Egypt.
Trial summary
The occurrence of sudden disruption of abdominal wall laparotomy wound is a major disaster and a major psychological trauma to the patient . Acute wound dehiscence is defined as postoperative separation of the abdominal musculoaponeurotic layers within 30 days after operation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Midline Laparotomy
- What is being tested?
- Midline abdominal closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 30 May 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient has risk factor for weak scar who underwent emergency laparotomy through midline incision .
Who cannot join
- Patients who had previous laparotomy.
- patients who underwent laparotomy through incisions other than midline incisions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ( Comparison Between ) Conventional and Modified Smead Jones Method for Abdominal Mass Closure in Emergency Midline Laparotomy
The occurrence of sudden disruption of abdominal wall laparotomy wound is a major disaster and a major psychological trauma to the patient . Acute wound dehiscence is defined as postoperative separation of the abdominal musculoaponeurotic layers within 30 days after operation.
Many risk factors were incriminated in causation of burst abdomen including malnutrition, anemia, hypo-proteinemia, pre and post-operative prolonged steroid therapy, peritonitis, malignancy, jaundice, uremia and post-operative abdominal distension or cough.
Read more
Wound dehiscence may be related to the technique of closure of abdomen and the sutures used. Numerous studies have been conducted evaluating many closure techniques and suture materials.
There is a number of studies evaluating various closure techniques and suture materials to prevent wound dehiscence following emergency midline laparotomy. In developing countries such as India, most patients operated as an emergency develop wound dehiscence such as they have prolonged intraperitoneal sepsis and malnutrition.
The current opinion for closure of a midline incision is mass closure with non-absorbable or slowly absorbable suture . Tension is distributed evenly along the length of the wound.
The standard technique for abdominal closure is 'mass closure' (closing all layers of the abdominal wall, excluding the skin), usually with nonabsorbable sutures, although 'slow-resorbing' sutures such as polydioxanone (PDS) are also widely used .
In Smead-Jones method of closure tension between two loops is distributed in such a way that the fascial edges are well approximated. Originally described method was interrupted. Continuous method has advantage of being faster and has less risk of wound dehiscence due to dynamic distribution of increased tension in postoperative period due to see-saw effect. We proposed modification of original Smead-Jones technique by doing it in continuous manner to increase the benefits and found this method to be fast, cost-effective, equally effective in controlling wound infection and better than interrupted technique to prevent wound dehiscence.
- Conditions
- Midline Laparotomy
- Being tested
- Midline abdominal closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midline abdominal closureProcedure or surgery
Abdominal Closure in Emergency Midline Laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Group A: Linea alba was closed with conventional continuous technique . | Active comparator | Group A: 25 patients included . Linea alba will be closed with conventional continuous technique . Receives: Procedure: Midline abdominal closure |
| Group B: Linea alba was closed with Modified Smead Jones technique with Far-near near-far technique. | Active comparator | Group B:25 patients included. Linea alba will be closed with Modified Smead jones technique with Far-near near-far technique. Receives: Procedure: Midline abdominal closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of burst abdomen post operative
Number of burst abdomen postoperative in emergency midline laparotomy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Nov 2021
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Midline LaparotomyStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adham Kadry Metawee, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199974
- Sponsor's protocol ID
- soh-med-21-12-08
- Status last verified
- Jun 2022
- First submitted
- 13 Dec 2021
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sajid MS, Parampalli U, Baig MK, McFall MR. A systematic review on the effectiveness of slowly-absorbable versus non-absorbable sutures for abdominal fascial closure following laparotomy. Int J Surg. 2011;9(8):615-25. doi: 10.1016/j.ijsu.2011.09.006. Epub 2011 Oct 30.
PubMed 22061310Begum B, Zaman R, Ahmed M, Ali S. Burst abdomen-A preventable morbidity. Mymensingh Med J. 2008 Jan;17(1):63-6.
PubMed 18285735Rucinski J, Margolis M, Panagopoulos G, Wise L. Closure of the abdominal midline fascia: meta-analysis delineates the optimal technique. Am Surg. 2001 May;67(5):421-6.
PubMed 11379640
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ( Comparison Between ) Conventional and Modified Smead Jones Method for Abdominal Mass Closure in Emergency Midline Laparotomy
- ClinicalTrials.gov ID
- NCT05199974
- Acronym / sponsor ID
- soh-med-21-12-08
- Conditions
- Midline Laparotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 20 Jan 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.
The occurrence of sudden disruption of abdominal wall laparotomy wound is a major disaster and a major psychological trauma to the patient . Acute wound dehiscence is defined as postoperative separation of the abdominal musculoaponeurotic layers within 30 days after operation.
Many risk factors were incriminated in causation of burst abdomen including malnutrition, anemia, hypo-proteinemia, pre and post-operative prolonged steroid therapy, peritonitis, malignancy, jaundice, uremia and post-operative abdominal distension or cough.
Wound dehiscence may be related to the technique of closure of abdomen and the sutures used. Numerous studies have been conducted evaluating many closure techniques and suture materials.
There is a number of studies evaluating various closure techniques and suture materials to prevent wound dehiscence following emergency midline laparotomy. In developing countries such as India, most patients operated as an emergency develop wound dehiscence such as they have prolonged intraperitoneal sepsis and malnutrition.
The current opinion for closure of a midline incision is mass closure with non-absorbable or slowly absorbable suture . Tension is distributed evenly along the length of the wound.
The standard technique for abdominal closure is 'mass closure' (closing all layers of the abdominal wall, excluding the skin), usually with nonabsorbable sutures, although 'slow-resorbing' sutures such as polydioxanone (PDS) are also widely used .
In Smead-Jones method of closure tension between two loops is distributed in such a way that the fascial edges are well approximated. Originally described method was interrupted. Continuous method has advantage of being faster and has less risk of wound dehiscence due to dynamic distribution of increased tension in postoperative period due to see-saw effect. We proposed modification of original Smead-Jones technique by doing it in continuous manner to increase the benefits and found this method to be fast, cost-effective, equally effective in controlling wound infection and better than interrupted technique to prevent wound dehiscence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Linea alba was closed with conventional continuous technique . | Active comparator | Procedure: Midline abdominal closureGroup A: 25 patients included . Linea alba will be closed with conventional continuous technique . |
| Group B: Linea alba was closed with Modified Smead Jones technique with Far-near near-far technique. | Active comparator | Procedure: Midline abdominal closureGroup B:25 patients included. Linea alba will be closed with Modified Smead jones technique with Far-near near-far technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient has risk factor for weak scar who underwent emergency laparotomy through midline incision .
Key exclusion criteria (2 listed)
- Patients who had previous laparotomy.
- patients who underwent laparotomy through incisions other than midline incisions.
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 |
|---|---|---|
| Midline abdominal closureAbdominal Closure in Emergency Midline Laparotomy | Procedure or surgery | Group A: Linea alba was closed with conventional continuous technique ., Group B: Linea alba was closed with Modified Smead Jones technique with Far-near near-far technique. |
Primary outcome
Number of burst abdomen post operative
Time frame: 1 month
Number of burst abdomen postoperative in emergency midline laparotomy
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 7 Jun 2022.
- Background: PubMed 22061310Sajid MS, Parampalli U, Baig MK, McFall MR. A systematic review on the effectiveness of slowly-absorbable versus non-absorbable sutures for abdominal fascial closure following laparotomy. Int J Surg. 2011;9(8):615-25. doi: 10.1016/j.ijsu.2011.09.006. Epub 2011 Oct 30.
- Background: PubMed 18285735Begum B, Zaman R, Ahmed M, Ali S. Burst abdomen-A preventable morbidity. Mymensingh Med J. 2008 Jan;17(1):63-6.
- Background: PubMed 11379640Rucinski J, Margolis M, Panagopoulos G, Wise L. Closure of the abdominal midline fascia: meta-analysis delineates the optimal technique. Am Surg. 2001 May;67(5):421-6.
- Individual participant dataSharing planned: No
Related trials for Midline Laparotomy
Active, not recruiting
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
Open Midline Laparotomy
Recruiting
A One-year Follow-up of Incisional Hernia Formation Between Device Assisted and Manual Laparotomy Closure
Incisional Hernia After Midline Laparotomy, Colorectal Cancer
Not yet recruiting
Analgesic Outcomes of Ultrasound-Guided QLB vs TAP Block in Midline Laparotomy
Postoperative Pain, Midline Laparotomy
Not yet recruiting
Prophylactic Mesh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT)
Incisional Hernia After Midline Laparotomy, Emergency Abdominal Surgery
Recruiting
Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy
Wound Complication, Surgical Site Infection (SSI)
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 Midline abdominal closure in people with Midline Laparotomy, run by Sohag University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 7 Jun 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 Egypt. 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?
Number of burst abdomen post operative (time frame: 1 month). 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 NCT05199974, which also lists 3 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 7 Jun 2022.