Does early intake of food and water after gynecological surgeries or cesarean section increase the risk of complications in women? A randomised control trial

Recruiting

Conditions: Other complications of obstetric surgery and procedures,

Registration Number: CTRI/2020/07/026852

Lead Sponsor: All India Institute of Medical Sciences Jodhpur

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 226

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): AIIMS Jodhpur
🇮🇳
Jodhpur, RAJASTHAN, India
AIIMS Jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
ISHITA AGGARWAL
Principal investigator
9811322765
ishita03994@yahoo.com