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
|
|
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
|
|
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
|
|
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 surgicallyâ€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 evidenceâ€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 wellâ€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 |