Title of the project:  Role of Glycosylated Hemoglobin and C-reactive protein (CRP) as Predictors of Difficult Laparoscopic Cholecystectomy in Diabetic Patients

AIM:- To evaluate the role of glycosylated hemoglobin (HbA1c) and C-reactive protein (CRP) as predictors of difficult laparoscopic cholecystectomy in diabetic patients.

Objectives:-

1. To assess the role of glycosylated hemoglobin (HbA1c) as predictors of difficult Laparoscopic cholecystectomy in diabetic patients.

2. To assess the role of CRP as predictor of difficult Laparoscopic cholecystectomy in diabetic patients.

3. To determine the association of HbA1c and CRP levels with intraoperative findings and conversion rates.

4. To assess the role of HbA1c and CRP in post op complications.

Justification for study Laparoscopic cholecystectomy (LC) is the preferred method for treating symptomatic gallbladder disease due to its advantages over open surgery, such as less postoperative pain and quicker recovery. However, difficult laparoscopic cholecystectomy (DLC) remains a significant concern, leading to longer surgeries, higher complication rates, and extended hospital stays. Glycosylated hemoglobin (HbA1c) reflects long-term glycemic control, while CRP is a sensitive marker of systemic inflammation—both of which have been linked to altered immune response and tissue healing in diabetics. In the context of laparoscopic cholecystectomy, poor glycemic control and elevated inflammatory markers may correlate with factors such as dense adhesions, increased operative time, or conversion to open surgery. By investigating the predictive value of these biomarkers, this study aims to aid preoperative risk stratification, optimize perioperative management, and potentially improve surgical outcomes in diabetic patients.

Materials and methods:  

a) Inclusion and exclusion criteria:

Inclusion Criteria:

    Diabetic patients diagnosed with symptomatic gallstone disease undergoing elective laparoscopic cholecystectomy.

    Diabetic patients undergoing elective interval cholecystectomy.

Exclusion Criteria:

     Age less than 18 years.

     Patient with past history of perforated gallbladder and managed conservatively.

     Patients undergoing emergency cholecystectomy.

     Patients with previous upper abdominal surgery.

Detailed description of procedure / processes:

 Permissions and Clearances

   Ethics Committee approval obtained prior to study initiation.

   Written informed consent from each patient.

Recruitment Process

  Diabetic patients posted for elective/ interval laparoscopic cholecystectomy.

  Those meeting the inclusion criteria are invited to participate, provided with the participant Information Sheet, and asked to sign the Informed Consent Form.

Preoperative Assessment

Detailed clinical examination, standard labs (CBC, RFT, LFT, FBS, PPBS), HbA1c and CRP levels, Ultrasonography (USG)

 Intraoperative details based on Nassar Grading scale

Difficulty Scoring of Laparoscopic Cholecystectomy based on:

    Adhesions around the gallbladder

    Distortion of anatomy

    Gallbladder wall thickness/inflamed/fibrotic/contracted/impacted stone

    Empyema/mucocele

    Difficulty in Calot’s triangle dissection

    Need for conversion to open surgery

Post op follow up for Post op complications-

Jaundice/bile duct injury/ subhepatic hematoma/ subhepatic collection/ pancreatitis/ port site infection/ Wound infection

Follow up at 1-2 weeks and Follow up at 1 month (Follow up is standard of care, follow up will be through telephonic contact)

Outcome measures

  Identification of a correlation between HbA1c, CRP levels, and difficult LC.

  Establishment of potential cutoff values of said parameters for predicting difficult LC in diabetic patients (Nassar scoring)

  Improved preoperative risk stratification and surgical planning

  Potential risks and benefits The potential risks in the study include surgical complications such as Jaundice/bile duct injury/ subhepatic hematoma/ subhepatic collection/ pancreatitis/ port site infection/ Wound infection. However, all participants will undergo surgical protocols with appropriate monitoring and safety checks. The potential benefits include improved understanding of the role of glycosylated hemoglobin (HbA1c) and C-reactive protein (CRP) as predictors of difficult laparoscopic cholecystectomy in diabetic patients to aid in preoperative risk stratification, optimize perioperative management, and potentially improve surgical outcomes in diabetic patients.

  Ethical considerations and methods to address issues  Ethical Clearance for the study will be obtained from Institutional ethical committee(IEC) of Kasturba Medical College, Manipal prior to initiation. The study will also be registered with Clinical Trials Registry Of India (CTRI). Written informed consents will be taken from all the participants after explaining the study details, risks and benefits. Participants confidentiality will be maintained throughout, with no personal identifiers used in data collection or analysis. Any adverse events will be promptly reported to IEC, and any protocol amendments will undergo re approval before implementation.                     

Review of literature 

Laparoscopic cholecystectomy (LC) is considered the gold standard for the treatment of gallbladder diseases such as cholelithiasis and cholecystitis.  However, in certain cases, the surgery can be complicated by a range of factors, including anatomical variations, inflammation, and comorbid conditions. Among these comorbidities, diabetes mellitus (DM) is recognized as a significant risk factor for difficult laparoscopic cholecystectomy (DLC). The impact of diabetes on the surgical process is multifactorial, involving alterations in tissue healing, immune response, and an increased risk of complications such as infection and bile leakage. 

Reactive Protein (CRP) and Its Role in Surgical Outcomes

  C-reactive protein (CRP) is an acute-phase reactant protein that is produced by the liver in response to inflammation. Its levels rise in response to a variety of conditions, including infections, trauma, and chronic inflammatory diseases. CRP has been widely used as a marker of systemic inflammation and has shown potential as a predictor of surgical complications In the context of laparoscopic cholecystectomy, CRP levels are used to gauge the extent of inflammation and predict potential intraoperative difficulties. In diabetic patients, chronic low-grade inflammation often leads to elevated CRP levels, and these patients are at an increased risk of having more complicated surgeries. Some studies have suggested that preoperative CRP levels may help predict difficult laparoscopic procedures and postoperative complications. However, the predictive value of CRP specifically in the setting of diabetic patients undergoing cholecystectomy requires further investigation. 

Hemoglobin A1c (HbA1c) and Its Role in Surgery

 Hemoglobin A1c (HbA1c) is a well-established marker for long-term blood glucose control and reflects the average blood glucose levels over the past 2-3 months. HbA1c levels are crucial in managing diabetes and have been linked to a variety of surgical outcomes. Studies have shown that elevated HbA1c levels correlate with poor wound healing, an increased risk of infection, and delayed recovery after surgery. High HbA1c levels indicate poor glycemic control, which can impair immune function and increase the risk of infection, both of which can complicate the surgical process.

 In the context of laparoscopic cholecystectomy, several studies have indicated that patients with poorly controlled diabetes, as evidenced by high HbA1c levels, are more likely to experience difficulties during surgery. These difficulties may manifest as technical challenges during the operation, such as difficult dissection due to anatomical changes or adhesions, and an increased risk of postoperative complications, including infection and bile leakage. Furthermore, diabetic patients with elevated HbA1c levels have been shown to have a higher incidence of postoperative pancreatitis, wound infections, and delayed recovery, further complicating the clinical management of these patients.

The Impact of Diabetes on Laparoscopic Cholecystectomy

 Diabetes mellitus (DM) has been shown to affect various aspects of laparoscopic surgery. The chronic hyperglycemic state in diabetic patients can lead to microvascular damage, which impairs tissue perfusion and delays wound healing. Diabetic patients are also more likely to have gallbladder disease due to the effects of insulin resistance and obesity, both common in type 2 diabetes. Consequently, these patients are frequently referred for laparoscopic cholecystectomy, where they may face additional surgical challenges.

 Several studies have identified diabetic patients as having a higher likelihood of requiring conversion from laparoscopic to open surgery. This is attributed to factors such as the presence of dense adhesions, an increased risk of bleeding, and technical difficulties during the dissection of the gallbladder due to altered tissue planes (Saini et al., 2015). Moreover, the presence of diabetes has been linked to an increased incidence of postoperative complications, including infections, wound dehiscence, and delayed recovery. Therefore, it is crucial to identify diabetic patients who are at higher risk for a difficult procedure, allowing for better preoperative planning and optimized perioperative management.