Enhanced Recovery Program After Laparoscopic Colorectal Surgery During The Era Of COVID-19

NCT05240053 | Completed

• 1 other identifier: zagazig general surgey departe
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators included all patients who were subjected to laparoscopic colorectal surgery at investigators' center between ( December 2019 to December 2021) for benign \& malignant conditions. sample size was 50 patients , divided into 2 equal groups . Group 1: included 25 patients who were subjected to enhance recovery program after laparoscopic colorectal surgery . Group 2: included 25 patients who were subjected to traditional way - nothing by mouth until the resolution of ileus, then a fluid diet, followed by a regular diet after laparoscopic colorectal surgery.

Conditions

Colorectal Disorders

Keywords

enhanced oral recovery; , colorectal disorders

Outcome Measures

Primary Outcomes (1)

• incidence of complications after enhanced recovery program

  incidence of complications after after enhanced recovery program

  within one week after the surgery

Secondary Outcomes (1)

• incidence of mortality after enhanced recovery program

  within one month after the surgery

Study Arms (2)

group (1)

ACTIVE COMPARATOR

Group 1: included 25 patients who were subjected to enhance recovery program after laparoscopic colorectal surgery .

Other: enhanced recovery programe

group (2)

NO INTERVENTION

Group 2: included 25 patients who were subjected to traditional way

Interventions

enhanced recovery programe OTHER

Early postoperative analgesia , early oral intake , early mobilization , early removal of nasogastric tube \& drains if any. The patients in this group started clear fluid once they awaked from anesthesia , a full liquid diet on first postoperative day , normal diet on second day provided that there was no vomiting or abdominal distension. The patients in this group were instructed for early ambulation \& encouraged to stay out of the bed for 4 hours on first day postoperative , 6 hours in following day , 8 hours on subsequent days. Also they were encouraged to walk the length of 3 meters once on first day postoperative , twice on day 2 \& three times on subsequent days. Regarding analgesia in this group postoperatively , they were received fentanyl via an epidural catheter.

group (1)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with age ranged from 20-75 years
• patients who had no contraindication for laparoscopic surgery
• good general condition with American society of anesthesiology (ASA) I \& II

You may not qualify if:

• patients who had bad general condition (ASA ≥3)
• patients with age above 75 years
• patients with uncompensated cardiopulmonary disease , immunological disorders ,immunosuppressive therapy for any cause.
• Patients who had chronic liver disease
• patients who underwent emergency laparotomy and had a stoma created for them or those with metastasis

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharqua, 1185, Egypt

Location

Study Officials

• Said Mohamed Negm, MD

  ZAGAZIG UNIVERSITY HOSPITALS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of general surgery

Model Details: The investigators included all patients who were subjected to laparoscopic colorectal surgery at our center between ( December 2019 to December 2021) for benign \& malignant conditions. sample size was 50 patients , divided into 2 equal groups . Group 1: included 25 patients who were subjected to enhance recovery program after laparoscopic colorectal surgery . Group 2: included 25 patients who were subjected to traditional way - nothing by mouth until the resolution of ileus, then a fluid diet, followed by a regular diet after laparoscopic colorectal surgery.

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 15, 2022
• Study Start: December 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

EG (1)