Comparison of effects of early against conventional tube removal in decreasing the complications after pancreas and small intestine surgery

Not yet recruiting

Conditions: Diseases of the digestive system, (2) ICD-10 Condition: O||Medical and Surgical,

Registration Number: CTRI/2021/09/036527

Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research

Brief Summary: Allconsecutive patients who undergo minimally invasive or openpancreatoduodenectomy with drain fluid amylase on POD 1 (<5000IU/L) and POD3 (<350IU/L) in the Department of Surgery and Surgical gastroenterology willbe included in the study.

Drain will be placed intraoperatively for allpatients at the end of the procedure. After obtaining informed consent,eligible patients are randomized into two groups on POD 3 by a computergenerated allocation schedule to receive either early or conventional drain removal.

In both the groups, drain fluid amylaselevels are assessed on POD 1 and day 3. In Group 1 drain will be removedaccording to treating surgeons discretion whereas in group 2, the drain will beremoved on POD 3 after ruling out intra-abdominal collection by ultrasound.

Hospital stay, Pancreatic fistula, Intra abdominalcollections, Delayed gastric emptying, Gastrointestinal bleeding will beanalyzed in both the groups.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 86

Inclusion Criteria

All consecutive patients who undergo Pancreatoduodenectomy with drain fluid amylase on POD 1 (<5000IU/L) and POD 3 (<350IU/L) in the department of General Surgery and Surgical Gastroenterology JIPMER.

Exclusion Criteria

1.Less than 18 years 2.Early Post Pancreatectomy haemorrhage [Defined as onset <24 h after the end of the index operation) 3.Re-laparotomy within 72 hours from index operation 4.Sinister appearance of drain effluent (pancreatic juice) 5.Clinical suspect of biliary fistula 6.Peripancreatic fluid collection > 5cm (max diameter) at a routine transabdominal USG before randomization.
7.Surgeons decision for keeping the drain (>POD3) in study group for whatever reasons.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the length of hospital stay (LOS) between the early drain removal and conventional drain removal group in patients undergoing pancreatoduodenectomy.	To compare the length of hospital stay (LOS) by assessing on day 3, 10 and 30 (if not discharged)

Secondary Outcome Measures

Name	Time	Method
i)To compare the Pancreatic fistula rates among two groups	ii)To compare the rate of Intra abdominal collections among two groups

Trial Locations

Locations (1): JIPMER
🇮🇳
Pondicherry, PONDICHERRY, India
JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
DR SREE SUBRAMANIYAN S
Principal investigator
8015476825
sssubramani96@gmail.com