Enhanced Recovery Program After Laparoscopic Colorectal Surgery During The Era Of COVID-19
Condition: Colorectal Disorders
Study type: Interventional

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.
    

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.
    

Intervention name(s): enhanced recovery programe
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Prevention
Keywords: enhanced oral recovery; , colorectal disorders