| CTRI Number |
CTRI/2025/08/092348 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
03/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Special Support Stitching vs. Standard Stitching for Safer Abdominal Surgery
Recovery |
|
Scientific Title of Study
|
Effect of Retention versus Conventional midline closure in high-risk Laparotomy (RECON Trial): An open label randomized controlled trial |
| Trial Acronym |
RECON |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravi Gupta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery All India Institute of Medical Sciences Gorakhpur
Kunraghat Gorakhpur Uttar Pradesh 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9453302264 |
| Fax |
|
| Email |
ravikgmc2004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Gupta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery All India Institute of Medical Sciences Gorakhpur
Kunraghat Gorakhpur Uttar Pradesh 273008
UTTAR PRADESH
273008
India |
| Phone |
9453302264 |
| Fax |
|
| Email |
ravikgmc2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Gupta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery All India Institute of Medical Sciences Gorakhpur
Kunraghat Gorakhpur Uttar Pradesh 273008
UTTAR PRADESH
273008
India |
| Phone |
9453302264 |
| Fax |
|
| Email |
ravikgmc2004@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ravi Gupta |
| Address |
Department of General Surgery All India Institute of Medical Sciences Gorakhpur
Kunraghat Gorakhpur Uttar Pradesh 273008 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravi Gupta |
All India Institute of Medical Sciences(AIIMS) Gorakhpur |
Department of General Surgery
All India Institute of Medical Sciences Gorakhpur
Kunraghat Gorakhpur Uttar Pradesh 273008
Gorakhpur
UTTAR PRADESH |
9453302264
ravikgmc2004@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee All India Institute of Medical Sciences Gorakhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K251||Acute gastric ulcer with perforation, (2) ICD-10 Condition: K252||Acute gastric ulcer with both hemorrhage and perforation, (3) ICD-10 Condition: K255||Chronic or unspecified gastric ulcer with perforation, (4) ICD-10 Condition: K256||Chronic or unspecified gastric ulcer with both hemorrhage and perforation, (5) ICD-10 Condition: K261||Acute duodenal ulcer with perforation, (6) ICD-10 Condition: K262||Acute duodenal ulcer with both hemorrhage and perforation, (7) ICD-10 Condition: K265||Chronic or unspecified duodenal ulcer with perforation, (8) ICD-10 Condition: K266||Chronic or unspecified duodenal ulcer with both hemorrhage and perforation, (9) ICD-10 Condition: K271||Acute peptic ulcer, site unspecified, with perforation, (10) ICD-10 Condition: K272||Acute peptic ulcer, site unspecified, with both hemorrhage and perforation, (11) ICD-10 Condition: K275||Chronic or unspecified peptic ulcer, site unspecified, with perforation, (12) ICD-10 Condition: K276||Chronic or unspecified peptic ulcer, site unspecified, with both hemorrhage and perforation, (13) ICD-10 Condition: K281||Acute gastrojejunal ulcer with perforation, (14) ICD-10 Condition: K282||Acute gastrojejunal ulcer with both hemorrhage and perforation, (15) ICD-10 Condition: K285||Chronic or unspecified gastrojejunal ulcer with perforation, (16) ICD-10 Condition: K286||Chronic or unspecified gastrojejunal ulcer with both hemorrhage and perforation, (17) ICD-10 Condition: K315||Obstruction of duodenum, (18) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, (19) ICD-10 Condition: K403||Unilateral inguinal hernia, with obstruction, without gangrene, (20) ICD-10 Condition: K560||Paralytic ileus, (21) ICD-10 Condition: K561||Intussusception, (22) ICD-10 Condition: K562||Volvulus, (23) ICD-10 Condition: K565||Intestinal adhesions [bands] withobstruction (postinfection), (24) ICD-10 Condition: K570||Diverticulitis of small intestinewith perforation and abscess, (25) ICD-10 Condition: K572||Diverticulitis of large intestinewith perforation and abscess, (26) ICD-10 Condition: K574||Diverticulitis of both small and large intestine with perforation and abscess, (27) ICD-10 Condition: K578||Diverticulitis of intestine, partunspecified, with perforation and abscess, (28) ICD-10 Condition: C16||Malignant neoplasm of stomach, (29) ICD-10 Condition: C17||Malignant neoplasm of small intestine, (30) ICD-10 Condition: C18||Malignant neoplasm of colon, (31) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (32) ICD-10 Condition: C155||Malignant neoplasm of lower thirdof esophagus, (33) ICD-10 Condition: C22||Malignant neoplasm of liver and intrahepatic bile ducts, (34) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (35) ICD-10 Condition: C25||Malignant neoplasm of pancreas, (36) ICD-10 Condition: C26||Malignant neoplasm of other and ill-defined digestive organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Midline Closure |
This group midline will be closed with the running suture loop PDS II (Ethicon), one from cranial end and another from caudal end at the distance of 5 mm with of fascia bilaterally 5 mm (small bites) ensuring the suture to wound length ratio of 4:1. Both the sutures are knotted in between the midline with 7 knots. Skin will be closed with Ethilon 2-0 (Ethicon) interrupted. |
| Intervention |
RTL Closure |
Midline will be closed with the running suture loop PDS II (Ethicon), one from cranial end and another from caudal end at the distance of 5 mm with of fascia bilaterally 5 mm (small bites) ensuring the suture to wound length ratio of 4:1. Both the sutures are knotted in between the midline with 7 knots. Another interrupted retention sutures will be taken 2 cm from midline bilaterally taking full thickness of sheath, peritoneum, muscles and skin using Ethibond 5-O (Ethicon) at the distance of 2 to 4 (these sutures will be placed prior to midline PDS closure and knot of these sutures will be taken after closure of midline with PDS). Sutures will be incorporated in infant feeding tube 8 French and 6 to 7 knots will be taken with each suture. Skin will be closed with Ethilon 2-O (Ethicon) interrupted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who need to undergo a high risk primary midline laparotomy, age 18 years or more who will complete 1 year’s follow-up will be included. Patients included in high risk laparotomy cases will be those who need to undergo an emergency major abdominal operation OR elective major abdominal operation for malignant or inflammatory intra-abdominal diseases OR they had at least one of the following risk factors for postoperative wound failure—coexisting respiratory disease, intraabdominal infection, long-term use of steroids (more than 3 months), obesity, malnutrition, chemotherapy, diabetes, renal insufficiency
|
|
| ExclusionCriteria |
| Details |
Pregnant female, patients with serious psychiatric disorder and lack of compliance, poor control of septic source and poor intraperitoneal lavage before closure of abdomen, unable to follow-up 1 year, not giving consent. Patients who undergo re-laparotomy within 30 days of index surgery or died, patients who have had previous abdominal surgery will also be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Burst abdomen (BA) (evisceration): BA will be defined as defect in midline fascial closure within 30 days of index surgery. BA will be assessed by clinical evaluation or if uncertain on clinical evaluation then radiological imaging i.e ultrasonography will be performed.
Incisional hernia (IH): IH will be assessed in the 1 year of index surgery with clinical examination by an experienced clinician or by imaging with ultrasound/ CT scan by an experienced radiologist. IH will be defined as protrusion of peritoneal sac with content from midline defect. |
Burst abdomen (BA) (evisceration): BA will be defined as defect in midline fascial closure within 30 days of index surgery. BA will be assessed by clinical evaluation or if uncertain on clinical evaluation then radiological imaging i.e ultrasonography will be performed.
Incisional hernia (IH): IH will be assessed in the 1 year of index surgery with clinical examination by an experienced clinician or by imaging with ultrasound/ CT scan by an experienced radiologist. IH will be defined as protrusion of peritoneal sac with content from midline defect. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Surgical site infection will be defined by using CDC guideline within 30 days of index surgery |
3 days post-operatively, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Wound complication will be defined by using Southampton Scoring Systems within the 30 days of index surgery. |
3 days post-operatively, 1 week, 2 weeks, 3 weeks, 4 weeks |
| Post operative pain will be assessed with VAS (visual analogue scale) on day 1, 3, 7 ,14. |
post-operative day 1,3,7 and 14 |
| Postoperative complication will be assessed with Clavien Dindo classification |
3 days post-operatively, 1 week, 2 weeks, 3 weeks, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
14/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
One of the delayed consequences following
the laparotomy due to fascial dehiscence are incisional hernias. The occurrence
of incisional hernias one-year post-surgery ranges from 9% to 20%, but may
exceed 35% to 40 % in patients with risk factors. This signifies
a significant health and social issue. An incisional hernia frequently
correlates with discomfort and restrictions in occupational activities. Despite
the limited consensus among surgeons regarding treatment strategies for
incisional hernias, these conditions frequently necessitate surgical
intervention, accompanied by associated perioperative risks. An
early postoperative fascial dehiscence results in the development of a ruptured
abdomen. The research indicates that the reoperation rate for a burst abdomen
ranges from 1% to 3%.
The
European Hernia Society guidelines advocate for a continuous suture utilizing a
slowly absorbable monofilament thread in the ’small bites’ technique (stitch
distance from the fascia edge 5–8 mm, inter-stitch distance 5 mm) with a
suture-to-wound length ratio of no less than 4:1 for the closure of elective
midline laparotomies.
No
specific suturing approach can be recommended for the closure of laparotomies
in emergency procedures, which carry a heightened risk of wound dehiscence,
abdominal rupture, and therefore, incisional hernia, due to insufficient data. The incidence of fascia dehiscence is associated with various risk factors,
including hypoalbuminemia, anemia, malnutrition, chronic pulmonary illnesses,
and postoperative vomiting and ileus. In such instances, certain
studies advocate for the application of supplementary retention sutures to
alleviate stress on the fascia suture, hence facilitating improved healing.
This approach can diminish the incidence of burst abdomen and hernias, and its
application has been proposed as a therapeutic option for addressing fascial dehiscence. However, the European Hernia Society’s guidelines do not endorse the routine
application of this fascia closure procedure due to insufficient data. Moreover, these sutures are linked to heightened pain, postoperative
discomfort, skin maceration, and wound problems, as they traverse the entire
abdominal wall, including the fascia, subcutaneous fat, and skin. This approach
has not been widely embraced for routine application. Prophylactic retention
sutures may be a viable choice for high-risk patients with several risk factors
to prevent fascial dehiscence without significant postoperative sequelae. Nevertheless, projected data are insufficient. |