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Colorectal DisordersNCT05240053

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

A study testing enhanced recovery programe in people with Colorectal Disorders, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Colorectal Disorders
What is being tested?
enhanced recovery programe
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Dec 2019to 1 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Zagazig University Hospitals

    Zagazig, Sharqua, 1185

Other trials in Egypt

About this study

Official title: Enhanced Recovery Program After Laparoscopic Colorectal Surgery During The Era Of COVID-19 : A Randomized Controlled Trial

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.

Read the detailed description

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. The study was approved by the research and Ethics committee of our university and performed in accordance with the code of ethics of the world medical association (Declaration of Helsinki) for studies involving humans. A written informed consent was obtained from all participants.

Sample size The sample size was calculated using open Epi program . 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.

Perioperative measures:

In this prospective randomized controlled trials , all patients were subjected to the followings: patients were selected by randomization method , Full history taking , Complete physical examination , laboratory investigations ( complete blood picture , liver and kidney functions , coagulation profile , tumor marker tests, serum electrolytes) , patients were assessed radio- logically by barium enema, abdominal ultrasound ,pelvic and abdominal CT, bone survey and chest X-ray in addition to colonoscopy and biopsy for diagnosis of colorectal cancer, all cases were well prepared by correction of electrolytes and acid-base disturbance , all cases were subjected to colonic preparation.

Surgical techniques :

Group (1) : 25 patients were subjected to enhanced recovery program after laparoscopic colorectal surgery for either benign or malignant condition including different types of anastomosis either handmade or staplers assisted. They were informed about the program and what was to happen during hospitalization , food intake , ambulation after surgery , fasting 2 hours for liquid \& 6 hours for solid. Prophylactic antibiotic was given . also thromboembolism prophylaxis was given . Good nutrition for the patients was achieved .both crystalloid \& colloid with vasopressor were given intraoperative with caution to keep intraoperative fluid less than 3000-3500ml with no use of drains \& nasogastric tube if possible or as can as possible. 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 (2) : included 25 patients who were subjected to conventional rehabilitation program after laparoscopic colorectal resection for benign or malignant conditions . they were subjected to nothing per mouth for 5 days until resolution of ileus , fluid diet followed by usual diet . patients were mobilized by nurses according to patient wellness . instructions about importance of mobilization were given to the patients. Pain was managed in this group by paracetamol \& non- steroidal anti-inflammatory drug (NSAID) infusion .

Patients in both groups were eligible for discharge when they were self-caring, were tolerating oral fluid and diet, had bowel function, and were independently mobile.

Being tested
enhanced recovery programe
Keywords
enhanced oral recovery, , colorectal disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • enhanced recovery programeOther

    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.

Study groups in NCT05240053
Study groupRoleWhat they receive
group (1)Active comparatorGroup 1: included 25 patients who were subjected to enhance recovery program after laparoscopic colorectal surgery .
Receives: Other: enhanced recovery programe
group (2)No interventionGroup 2: included 25 patients who were subjected to traditional way

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of complications after enhanced recovery program

    incidence of complications after after enhanced recovery program

    Measured: within one week after the surgery

Secondary outcomes (1)
  1. incidence of mortality after enhanced recovery program

    incidence of mortality after enhanced recovery program

    Measured: within one month after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2022
  2. Study start1 Dec 2019
  3. Primary completion1 Dec 2021
  4. Study completion1 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05240053
Sponsor's protocol ID
zagazig general surgey departe
Status last verified
Feb 2022
First submitted
11 Feb 2022
Last updated
15 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing enhanced recovery programe in people with Colorectal Disorders, run by Zagazig University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of complications after enhanced recovery program (time frame: within one week after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.

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