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CTRI Number  CTRI/2020/07/026852 [Registered on: 28/07/2020] Trial Registered Prospectively
Last Modified On: 03/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Does early intake of food and water after gynecological surgeries or cesarean section increase the risk of complications in women? A randomised control trial 
Scientific Title of Study   Impact of Early versus late initiation of oral feeding after major benign gynecologic procedures and Cesarean Deliveries on rate of postoperative complications - A Randomised Control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr ISHITA AGGARWAL 
Designation  PG Student ,Department of Obstetrics and Gynaecology 
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  Department of Obstetrics and Gynecology , AIIMS Jodhpur Basni Industrial Area MIA 2nd Phase Basni
AIIMS , Jodhpur Basni Industrial Area MIA 2nd Phase Basni
Jodhpur
RAJASTHAN
342005
India 
Phone  9811322765  
Fax    
Email  ishita03994@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr PRATIBHA SINGH 
Designation  Head of the department , Department of Obstetrics and Gynaecology , AIIMS Jodhpur 
Affiliation  AII India Institute of Medical Sciences 
Address  AIIMS residential complex, AIIMS Jodhpur Basni Industrial Area MIA 2nd Phase Basni
AIIMS, Jodhpur Basni Industrial Area MIA 2nd Phase Basni
Jodhpur
RAJASTHAN
342005
India 
Phone  8003996941  
Fax    
Email  drpratibha69@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr ISHITA AGGARWAL 
Designation  PG student, Department of Obstetrics and Gynaecology , AIIMS Jodhpur 
Affiliation  AII India Institute of Medical Sciences 
Address  AIIMS Jodhpur Basni Industrial Area MIA 2nd Phase Basni
AIIMS , Jodhpur Basni Industrial Area MIA 2nd Phase Basni
Jodhpur
RAJASTHAN
342005
India 
Phone  9811322765  
Fax    
Email  ishita03994@yahoo.com  
 
Source of Monetary or Material Support  
AIIMS Jodhpur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Jodhpur 
Address  AIIMS Jodhpur Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ISHITA AGGARWAL  AIIMS Jodhpur  Department of Obstetrics and Gynaecology AIIMS Jodhpur Basni Industrial Area MIA 2nd Phase Basni
Jodhpur
RAJASTHAN 
9811322765

ishita03994@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O754||Other complications of obstetric surgery and procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional initiation of oral feeds during post operative period following cesarean section and major gynaecological surgeries  Subjects will receive conventional feeding (oral fluid and food) after 12 hrs in postoperative period irrespective to intestinal sounds, flatus or stool passage. 
Intervention  Early initiation of oral feeds during post operative period following cesarean section and major gynaecological surgeries   Subjects will receive early oral fluids with in 3 hrs in postoperative period with semisolid food after 6 hrs post operatively if Bowel sounds are present (checked by investigator.) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  Primigravida and Previous one or two cesarean section , between age group of 18-40 years, with singleton pregnancy undergoing Uncomplicated Cesarean section -under regional anesthesia will be recruited postoperatively after signing written informed consent.
All subjects, between age 18-70yrs undergoing uncomplicated major benign gynecologic procedure will be recruited postoperatively after signing written informed consent.
 
 
ExclusionCriteria 
Details  1. Age >70yrs, <18yrs , multiple pregnancy , Medical disorders as (hypertension, diabetes, liver or kidney diseases)
2. Complications during surgery as excessive bleeding, intestinal injury, or urinary bladder injury.
3. Cancer surgery.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of the rate of complications (Infections/bleeding/postoperative ileus) between women with early feeding (within 6hrs ) v/s late feeding (after 12hrs) of major benign gynaecologic procedures or caesarean deliveries.  till Patient is discharged 
 
Secondary Outcome  
Outcome  TimePoints 
comparison of the duration of hospital stay among above mentioned study groups.  till patient is discharged 
comparison of the rate of return of gastrointestinal functions(bowel sounds, passage of flatus) among the two groups  during hospital stay 
 
Target Sample Size   Total Sample Size="226"
Sample Size from India="226" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/07/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Abdominal surgery plays a major role in the treatment of various benign gynaecologic disorders, including uterine fibroids, endometriosis, ovarian cysts and benign ovarian mass. In this regard, hysterectomy and removal of ovarian cysts and deliveries by cesarean section are commonly performed procedures. Traditionally, it is advised that after an uncomplicated surgery, clear liquids may be given to patients on the first postoperative day following the return of bowel movements. After flatus is passed, the diet should be accelerated to a regular diet as tolerated by the patient.This is because, there is a widespread belief that intestinal stasis /paralytic ileus( transient state of abnormal bowel motility), follows all abdominal surgeries.Clinically, this condition ranges from a decreased appetite shortly after surgery to prolonged postoperative nausea, vomiting, and nutritional compromise. Postoperative ileus has been more specifically defined as at least two episodes of emesis of at least 100mL each within a 24-hour period, with associated abdominal distention and absent bowel sounds.The exact cause of this clinical phenomenon is unknown, but proposed mechanisms include stimulation of pain fibres, excessive sympathetic tone, and the release of inhibitory neurotransmitters from the gut wall.  There has been concern that early oral intake would result in vomiting and severe paralytic ileus with subsequent aspiration pneumonia, wound dehiscence (break down), and anastomotic leakage (leakage of surgically‐created connections between parts of the intestine). This belief has become surgical dogma, unsupported by scientific evidence.Recently, the practice of delayed postoperative oral intake has been challenged by evidence from several gastrointestinal physiologic studies that examine contractile activity of the intestine. Gastric emptying and small intestinal absorptive capacity resume on the first postoperative day while colonic activity normally returns within 48 hours after surgery. These data suggest that postoperative ileus may not occur as a paralysis of the entire bowel with complete absence of any functional contractile activity, as is conventionally assumed. If postoperative ileus takes place, it is usually transient and not clinically significant. It is also known that typically the stomach and pancreas secrete one to two litres of fluid daily which are readily absorbed in the small intestine. Women after surgery without a naso-gastric tube are therefore tolerating high volumes of fluid even though nothing is given orally. In addition, there are studies demonstrating that physical signs suggestive of resolution of postoperative ileus are not well correlated with the incidence of nausea and vomiting. Based on these findings, withholding oral intake until resolution of postoperative ileus is not an evidence‐based practice, and may also be unnecessary.Following surgery, optimal nutritional status and maintenance of bowel function contribute significantly to wound healing. Early oral intake has also been suggested to be an effective alternative in postoperative stress ulcer prophylaxis as it helps to maintain strength of bowel mucosa. In patients receiving early oral intake, the risk of sepsis is reduced because of decreased bacterial colonisation and reduced migration through defects on the bowel mucosa into blood circulation. Furthermore, an improved sense of well‐being was observed in patients who ate sooner. This psychological aspect contributes considerably to the entire postoperative recovery process. Cost effectiveness is another potential advantage of early feeding scheme, as those who begin eating sooner tend to have a shorter length of hospital stay. It is hypothesized that after uncomplicated cesarean delivery or major benign gynaecologic procedures performed under anaesthesia, oral hydration can be initiated as early as 3 hours after the operation, without significant adverse effects. The scope of this review is focused on a specific group of patients (Indian population), so that results may be more directly applicable. A larger, heterogeneous group of patients (e.g. gynaecology and general surgery patients combined) could potentially complicate results and delay applicability, due to different courses of diseases and operative characteristics

 
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