Relaparotomy Study - A prospective analysis of the standard of care and outcomes of patients undergoing relaparotomy with one randomized step (fascial closure)

Conditions

Abdominal re-operations Primary laparotomy

Golling M, Breul V, Zielska Z, Baumann P.

2024-01-293 citations

10.1007/s10029-023-02927-4

Effect of Metformin on HIF-1α Signaling and Postoperative Adhesion Formation

Marvin Biller, Christopher Tuffs, Marc Bleul, Dinh Thien-An Tran, Mareen Dupovac et al. (10 authors)

Journal of the American College of Surgeons2022-04-088 citations

10.1097/xcs.0000000000000205

Standard of Care and Outcomes of Primary Laparotomy Versus Laparotomy in Patients with Prior Open Abdominal Surgery (ReLap Study; DRKS00013001).

Tran DT, Klotz R, Harnoss JC, Heger P, Ritter AS, Doerr-Harim C, Knebel P, Schneider M, Büchler MW, Diener MK, Probst P.

2021-01-285 citations

10.1007/s11605-020-04904-z

Randomised-controlled feasibility trial on abdominal wall closure techniques in patients undergoing relaparotomy (ReLap study; DRKS00013001).

Probst P, Tran DT, Hüttner FJ, Harnoss JC, Heger P, Ritter AS, Doerr-Harim C, Mihaljevic AL, Knebel P, Schneider M, Büchler MW, Diener MK.

2020-06-067 citations

10.1007/s00423-020-01903-1

Interventions

Group 1: every patient that is undergoing primary laparotomy due to their disease Group 2: every patient that is undergoing relaparotomy due to their disease and whose fascial closure will be performe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: experimental group: relaparotomy of every kind, not depending on the underlying disease; control group: primary laparotomy of every kind, not depending on the underlying desease

Exclusion criteria

Exclusion criteria: primary reason of the relaparotomy is an incisional hernia or laparostoma; surgery in retroperitoneum without transperitoneal acces, urgency operation; underaged or non-compliant patient

Design outcomes

Primary

Measure	Time frame
Due to the lack of existing literature it was not possible to choose a confirmatory statistical design with one primary endpoint. Standard of care of the surgical procedure compared between Primary and re-laparotomy: assessed intraoperatively. Adhesions according to the „Peritoneal adhesion index“ with translational correlation: assessed intraoperatively with tissue sample from normal peritoneum and if applicable from adhesions. Postoperative complications according to Clavien-Dindo assessed until discharge or at least at postoperative day 30. Comprehensive Complication Index assessed until discharge or at least at postoperative day 30. Incisional hernia assessed after 12 months Length of Hospital stay assessed as the difference of days between the index operation and day of discharge. Length of stay on ICU assessed until discharge or at least at postoperative day 30. Bowel movements assessed as days between the indexoperation and the day of first flatus or stool. Quality of life (EQ5D: Pre-operative, discharge and after 12 months) Additional for patients undergoing relaparotomy: Feasibility of fascial closure with both suture techniques according to the operating surgeon. Technique of fascial closure: material and technique actually used. Time to close abdomen: time between start of fascial closure and end of skin closure. Burst abdomen assessed as the need for a reoperation due to fascial insufficency during the hospital stay.	—

Measure

Time frame

Due to the lack of existing literature it was not possible to choose a confirmatory statistical design with one primary endpoint. Standard of care of the surgical procedure compared between Primary and re-laparotomy: assessed intraoperatively. Adhesions according to the „Peritoneal adhesion index“ with translational correlation: assessed intraoperatively with tissue sample from normal peritoneum and if applicable from adhesions. Postoperative complications according to Clavien-Dindo assessed until discharge or at least at postoperative day 30. Comprehensive Complication Index assessed until discharge or at least at postoperative day 30. Incisional hernia assessed after 12 months Length of Hospital stay assessed as the difference of days between the index operation and day of discharge. Length of stay on ICU assessed until discharge or at least at postoperative day 30. Bowel movements assessed as days between the indexoperation and the day of first flatus or stool. Quality of life (EQ5D: Pre-operative, discharge and after 12 months) Additional for patients undergoing relaparotomy: Feasibility of fascial closure with both suture techniques according to the operating surgeon. Technique of fascial closure: material and technique actually used. Time to close abdomen: time between start of fascial closure and end of skin closure. Burst abdomen assessed as the need for a reoperation due to fascial insufficency during the hospital stay.

—

Countries

Germany

Contacts

Public ContactPascal Probst

Universitätsklinikum HeidelbergKlinik für Allgemein-, Viszeral- und Transplantationschirurgie

pascal.probst@med.uni-heidelberg.de+496221 56 36337

Outcome results

None listed