CompletedNot Applicable

Open Versus Total Laparoscopic Pancreaticoduodenectomy

Egypt48 participantsStarted 2022-09-01

Plain-language summary

The goal of this clinical trial is to learn more about Total Laparoscopic pancreaticoduodenectomy ( TLPD ) which is performed for participants with pancreatic tumors using the laparoscope. TLPD is an operation that includes excision of the tumor with adjacent parts of the head of the pancreas, the duodenum and the part of the external biliary system . In the final step during surgery, and to reconnect the bowel after excision of the tumor, multiple anastomoses or connections will be made by the surgeon. To get valid results , the investigators performed this randomized controlled trial that compare TLPD with the traditional technique used to remove these tumors through open pancreaticoduodenectomy ( OPD ). The main questions this study aims to answer are: Is TLPD superior to open pancraticoduodenectomy ( OPD ) regarding the adequacy of surgical tumor excision ? Is TLPD lower than OPD regarding the early complications after surgery ? Researchers will compare participants receiving TLPD with participants receiving OPD regarding : The time of the operation. The amount of blood lost during surgery. Complications that may happen during or after surgery. Time of recovery after surgery. Duration to amputation. Duration of hospital stay. The adequacy of resection .

Who can participate

Age range20 Years

SexALL

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Inclusion Criteria: * Patients presenting to the outpatient clinic of Kasr Alainy Hospitals with pancreatic head tumors, duodenal tumors, ampullary, or periampullary tumors who were candidates for either open or laparoscopic pancreaticoduodenectomy * Patients who accepted to participate in the study. Exclusion Criteria: * Patients who were deemed inoperable or irresectable tumors by preoperative investigations. * Patients with history of previous laparotomies. * Patients with complex ventral hernias.

What they're measuring

Length of hospital stay

Timeframe: From the date of surgery of every participant to the date of its discharge from hospital or death whichever comes first, assessed up to 3 months .

Length of postoperative surgical ICU stay

Timeframe: From the date of admission to SICU ( surgical intensive care unit ) after surgery to the date of discharge to ward or death whichever comes first, assessed up to 3 months .

Amount of blood loss

Timeframe: From start of surgery till skin closure

Amount of intraoperative blood transfusion

Timeframe: From start of surgery of every participant till skin closure

30-day mortality

Timeframe: From the date of surgery till one month after

Operative time in minutes

Timeframe: From time of skin incision till time of skin closure

Trial details

NCT IDNCT06661135

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-30

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