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.
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.
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.
- Conditions
- Colorectal Disorders
- 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 group | Role | What they receive |
|---|---|---|
| group (1) | Active comparator | Group 1: included 25 patients who were subjected to enhance recovery program after laparoscopic colorectal surgery . Receives: Other: enhanced recovery programe |
| group (2) | No intervention | Group 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.
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)
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.
- First posted15 Feb 2022
- Study start1 Dec 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Said Mohamed Said Abdou Negm, Zagazig University
- Investigators
- Said Mohamed Negm, MD, Principal investigator, ZAGAZIG UNIVERSITY HOSPITALS
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery Program After Laparoscopic Colorectal Surgery During The Era Of COVID-19 : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05240053
- Acronym / sponsor ID
- zagazig general surgey departe
- Conditions
- Colorectal Disorders
- Keywords
- enhanced oral recovery, , colorectal disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| group (1) | Active comparator | Other: enhanced recovery programeGroup 1: included 25 patients who were subjected to enhance recovery program after laparoscopic colorectal surgery . |
| group (2) | No intervention | –Group 2: included 25 patients who were subjected to traditional way |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enhanced recovery programeEarly 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. | Other | group (1) |
Primary outcome
incidence of complications after enhanced recovery program
Time frame: within one week after the surgery
incidence of complications after after enhanced recovery program
1 secondary outcome
incidence of mortality after enhanced recovery program
Time frame: within one month after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Said Mohamed Negm, MD principal investigator
ZAGAZIG UNIVERSITY HOSPITALS
1 site in 1 country: see every site and its status.
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.