Effectiveness of Minimally Invasive Hybrid Surgery for Ileal Interposition (MIHSII) for the Resolution of Type 2 Diabetes

Padmakumar Ramakrishnapillai, DNB¹, Madhukara Pai, MS¹, Farish Shams, MS¹, Praveen Kumar, PGDDM¹, Shaji P.G, MD¹, Anithadevi T.S, MSc¹, Sulfia P. J, MSc¹, and Vani Krishna, MSc¹

¹Sunrise Hospital, Kakkanad, Kochi, Kerala, India, 682030

^*Corresponding Author: Ramakrishnapillai Padmakumar, Consultant Surgeon, Department of Laparoscopic and Metabolic Surgery, Sunrise Hospital, Seaport-Airport Road, Kakkanad, Kochi 682030, India, Tel: +91-944-7230370; Fax: +91-484-2428917; E-mail: drrpadmakumar@gmail.com

Citation: Surgical Innovation 1–10 © The Author(s) 2015, Reprints and permissions: sagepub.com/journalsPermissions.nav sri.sagepub.com

DOI: 10.1177/1553350615589523

Abstract

AIM: To evaluate the effectiveness of minimally invasive hybrid surgery for ileal interposition (MIHSII), a novel procedure for type 2 diabetes (T2DM) in patients with a body mass index (BMI) <30 kg/m².

MATERIALS AND METHODS: MIHSII is an innovative technique in which sleeve gastrectomy is performed laparoscopically, followed by extracorporeal ileal interposition performed through a 5-cm midline incision. The procedure was performed on 31 T2DM patients, 17 males and 14 females. Their BMI values ranged from 21.8 kg/m2 to 29.8 kg/m2, with a mean BMI of 26.61 ± 2.61 kg/m2. The average duration of diabetes 8.14 ± 4.89 (range = 1-20) years. Most of the patients exhibited poorly controlled diabetes despite the use of oral hypoglycemic agents (OHAs) and/or insulin.

RESULTS: The mean preoperative glycosylated hemoglobin (HbA1c) for the population was 8.86%. The mean HbA1c 1 year after surgery was 6.80%. The difference between the mean preoperative and 1-year postoperative HbA1c values was significant, at P < .05 (group 1: BMI = 18.5-24.99 kg/m2, t = 2.83, and P = .022; group 2: BMI = 25-29.99 kg/m2, t = 4.23, and P = .001). The resolution rate of diabetes was 80.48%; 48.57% experienced complete resolution, and 31.91% experienced partial resolution. The remaining 19.52% of patients exhibited a significant reduction in HbA1c, although the HbA1c levels did not fall below 6.5%, even with medications.

CONCLUSIONS: MIHSII is an innovative technique of metabolic surgery and is a cost-effective and minimal procedure for the resolution of T2DM in patients with BMI <30 kg/m2.

KEYWORDS:
gastric surgery, surgical education, image-guided surgery

INTRODUCTION
Type 2 diabetes mellitus (T2DM) is a common disease with numerous complications. Obesity is the leading cause of the increased incidence of T2DM in both developed and developing countries, but a large proportion of T2DM patients in European and, in particular, Asian countries are nonobese. Nonobese T2DM patients may progress to insulin treatment more rapidly than obese patients.1

According to the International Diabetes Federation, metabolic surgery is an appropriate treatment for people with T2DM and body mass index (BMI) >35 kg/m2 who fail to achieve the recommended treatment targets with medical therapies, especially when other major comorbidities are present. Surgery should be considered as an alternative treatment option in patients with BMI between 30 and 35 kg/m2. In Asian patients and in some other ethnicities with increased risk, BMI action points may be reduced by 2.5 kg/m2.

In nonobese patients with diabetes, the effectiveness of metabolic surgery is not well documented. Laparoscopic sleeve gastrectomy with ileal interposition (LSG+II) is an effective procedure for nonobese T2DM patients (BMI <30 kg/m2)3.

In LSG+II, sleeve gastrectomy is performed laparoscopically with endoscopic staplers, followed by the interposition of 170 cm of the distal small intestinal segment, to a region 30 cm from the duodenojejunal junction. The ileal interposition requires 6 endoscopic staplers for division and anastomosis of the small bowel (9 if stapler entry point closure by intracorporeal suturing is replaced with staplers). In minimally invasive hybrid surgery for ileal interposition (MIHSII), we performed sleeve gastrectomy laparoscopically, followed by extracorporeal ileal interposition through a small umbilical incision. The anastomosis was performed end-to-end with sutures. The benefits of MIHSII include fewer areas of anastomosis and, therefore, a reduction in the number of potential sites for leakage; additionally, MIHSII is cost-effective because the procedure requires fewer staplers. MIHSII is less timeconsuming and is easier to understand and practice. MIHSII can be accomplished without significant impairment of cosmesis.

The present study aimed to assess the effectiveness of this novel procedure in resolving T2DM in patients with BMI <30 kg/m2.

Materials and Methods

This was a nonrandomized retrospective study conducted on 31 type 2 diabetic patients who underwent MIHSII and were available for follow-up at Sunrise Hospital, Kochi, from July 2010 to May 2013. MIHSII is an innovative technique practiced at our center in which sleeve gastrectomy is performed laparoscopically, followed by ileal interposition through a 5-cm midline incision.

The study population consisted of 17 male and 14 female patients, all with BMI <30 kg/m2. The mean age of the patients was 45 ± 10.24 (range = 26-65) years. The average weight of the population was 75.44 ± 10.27 (range = 61-102.2) kg. Height varied from 148 to 187 cm, with an average height of 168.12 ± 9.57 cm. BMI ranged from a minimum of 21.8 kg/m2 to a maximum of 29.8 kg/m2, with a mean BMI of 26.61 ± 2.61 kg/m2; the mean BMI decreased to 23.39 within 6 months and 21.55 within 1 year of surgery (Table 1; Figure 1).

Preoperative parameters, such as BMI, glycosylated hemoglobin (HbA1c), and diabetic medications, were compared with those noted during periodic postoperative reviews at 1 month and 3, 6, and 12 months to check the resolution rates of diabetes.

Per the American Diabetes Association guidelines, complete resolution was defined as persistent HbA1c <6% in the absence of any diabetic medications for 12 months. Patients exhibiting a reduction of HbA1c to between 6% and 6.5% were considered to exhibit partial resolution. The patients with HbA1c values below the preoperative value but not below 6.5% with medications were considered to exhibit reduced HbA1c with medications. Patients with no significant improvement in HbA1c even on medications that were used preoperatively were considered to have failed the procedure.

Inclusion Criteria

All patients who underwent MIHSII were included in the study. Diabetic patients at our center who were unable to achieve adequate control of their diabetes were considered candidates for the procedure.

Exclusion Criteria

Patients with BMI >30 kg/m2 who underwent sleeve gastrectomy alone were excluded from this study as well as patients who did not participate in a 1-year follow-up.

Initial Assessment

All the patients underwent a thorough clinical evaluation by a team of doctors, including a metabolic surgeon, diabetologist, cardiologist, anesthesiologist, pulmonologist, dietician, and diabetes educator. An enquiry regarding the duration of T2DM and other obesity-related comorbidities, including hypertension, sleep apnea, fatty liver, dyslipidemia, polycystic ovarian disease, and infertility, was performed. An enquiry concerning the complications of diabetes mellitus, including renal impairment, neuropathy, retinopathy, cardiovascular involvement, and cerebrovascular involvement, was performed. The patient’s medications were also recorded. A physical examination to detect diabetic complications and investigations based on the protocols were conducted.

Indications for MIHSII

Those who have type 2 diabetes mellitus, with BMI <30 kg/m2, are considered for MIHSII.

Contraindications for MIHSII

Absolute contraindications

• patients with very low fasting c-peptide (<1 ng/mL);
• patients with GAD/IA2 positivity (latent autoimmune diabetes in adults);
• ASA (American Society of Anesthesiologists) grade IV/V;
• cirrhosis;
• patients on dialysis for diabetic nephropathy; and pregnancy
• Relative contraindications

patients <15 and >65 years old and
patients with a diabetic duration >15 years
Preoperative Care

The medical conditions of the patients were stabilized as best as possible. The patients were counseled regarding diet restrictions after the procedure and probable complications, including gastric or intestinal leak. The patients were admitted 1 day prior to the surgery and were maintained on a liquid diet for 24 hours. Preoperative antibiotics were administered, and informed consent for surgery was obtained (Figure 2).

Operative Technique

Sleeve gastrectomy was performed using a 5-port technique. The first port (12 mm) was placed at the midline immediately superior to the umbilicus, and the second port (10 mm) was placed toward the left of the first port. Three 3-mm ports were placed at the right hypochondrium, right midclavicular line, and left anterior axillary line. The greater omentum was divided close to the stomach along the greater curvature, preserving the epiploic arcade toward the omentum. A 38F bougie was placed per-orally, and under its guidance, the stomach was divided 5 to 6 cm proximal to the pylorus. Thus, using endostaples, a narrow stomach tube was created, and the entire fundus was resected. Methylene blue dye was instilled to check for gastric leak. The 12-mm incision was extended through the umbilicus to create a 5-cm midline incision, and the small bowel was exteriorized. The ileocecal junction was located, and a position 30 cm proximal to the junction was marked with the help of silk sutures. The duodenojejunal flexure was identified, and a position 30 cm distal to the flexure was also marked with the help of sutures. The small bowel was marked midway between these 2 points (Figure 3). Measurement of the small bowel was achieved using a sterile measuring scale.

The point of division was identified 30 cm distal to the duodenojejunal flexure. A suture with 1 long thread was placed toward the duodenojejunal flexure. A suture with 2 long threads was placed 5 cm distal to the first suture for the division of the bowel. The ileocolic junction was identified, and the third point of bowel division was located 30 cm proximal to the junction. A 2-tailed suture was placed proximally, and a 3-tailed suture was placed distally 5 cm apart. The 3-tailed suture was placed at the jejunoileal junction (midpoint of small bowel) followed by a single-tailed suture 5 cm apart proximally. The area between the 2 sutures represented the second point of bowel division.

The small bowel was divided at these points in conjunction with the division of the mesenteric arcade, and the proximal small-bowel segment was transposed distally isoperistaltically (Figures 4-6). The suturing aids the restoration of bowel continuity by reconnecting the single-tailed suture to single-tailed as the first anastomosis, the 2-tailed suture to 2-tailed as the second anastomosis, and the 3-tailed suture to the 3-tailed as the third anastomosis.

Thus, proximal jejuno-ileal, middle ileo-jejunal, and distal jejuno-ileal anastomoses were performed with extracorporeal 2-layer hand-sewn suture anastomosis using 3-0 polyglactin 910 and 3-0 silk sutures. In summary, 1-2, 3-1, 2-3, the 3 sites of division of the small bowel, were converted to 1-1, 2-2, 3-3 of bowel anastamosis. The mesenteric defect was closed to prevent internal herniation, using 3-0 silk sutures (Figure 7).

Postoperative Care

Oral clear fluids were initiated after 48 hours. For the next 2 weeks, the patients were maintained on a clearliquid diet. Vitamin supplements and proton pump inhibitors were also provided to the patients. After 2 weeks, a vegetable- and protein-based diet was initiated, followed by a normal diet in 1 month’s time. Tight control of diabetes was maintained in the postoperative period, with insulin as required.